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COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04392219
Recruitment Status : Completed
First Posted : May 18, 2020
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ridgeback Biotherapeutics, LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Coronavirus
Interventions Drug: EIDD-2801
Drug: Placebo
Enrollment 130
Recruitment Details  
Pre-assignment Details The same 10 participants started and completed the Part 200 mg EIDD-2801 (Fasted) and Part 200 mg EIDD-2801 (Fed) arms.
Arm/Group Title Part 1 - Placebo Part 1 - 50 mg EIDD-2801 Part 1 - 100 mg EIDD-2801 Part 1 - 200 mg EIDD-2801 Part 1 - 400 mg EIDD-2801 Part 1 - 600 mg EIDD-2801 Part 1 - 800 mg EIDD-2801 Part 1 - 1200 mg EIDD-2801 Part 1 - 1600 mg EIDD-2801 Part 2 - 200 mg EIDD-2801 (Fasted/Fed) Part 3 - Placebo Part 3 - 50 mg EIDD-2801 Part 3 - 100 mg EIDD-2801 Part 3 - 200 mg EIDD-2801 Part 3 - 300 mg EIDD-2801 Part 3 - 400 mg EIDD-2801 Part 3 - 600 mg EIDD-2801 Part 3 - 800 mg EIDD-2801
Hide Arm/Group Description Participants were randomized to receive a single oral dose of Placebo (fasted). Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed). Participants were randomized to receive a twice daily dosing of Placebo capsules (fasted). Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted).
Period Title: Overall Study
Started 16 6 6 6 6 6 6 6 6 10 14 6 6 6 6 6 6 6
Completed 16 6 6 6 6 6 6 6 6 10 14 6 6 6 6 6 6 6
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Part 1 - Placebo Part 1 - 50 mg EIDD-2801 Part 1 - 100 mg EIDD-2801 Part 1 - 200 mg EIDD-2801 Part 1 - 400 mg EIDD-2801 Part 1 - 600 mg EIDD-2801 Part 1 - 800 mg EIDD-2801 Part 1 - 1200 mg EIDD-2801 Part 1 - 1600 mg EIDD-2801 Part 2 - 200 mg EIDD-2801 (Fasted/Fed) Part 3 - Placebo Part 3 - 50 mg EIDD-2801 Part 3 - 100 mg EIDD-2801 Part 3 - 200 mg EIDD-2801 Part 3 - 300 mg EIDD-2801 Part 3 - 400 mg EIDD-2801 Part 3 - 600 mg EIDD-2801 Part 3 - 800 mg EIDD-2801 Total
Hide Arm/Group Description Participants were randomized to receive a single oral dose of Placebo (fasted). Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed). Participants were randomized to receive two daily dosing of Placebo capsules (fasted). Participants were randomized to receive two daily dosing of 50 mg EIDD-2801 capsules (fasted). Participants were randomized to receive two daily dosing of 100 mg EIDD-2801 capsules (fasted). Participants were randomized to receive two daily dosing of 200 mg EIDD-2801 capsules (fasted). Participants were randomized to receive two daily dosing of 300 mg EIDD-2801 capsules (fasted). Participants were randomized to receive two daily dosing of 400 mg EIDD-2801 capsules (fasted). Participants were randomized to receive two daily dosing of 600 mg EIDD-2801 capsules (fasted). Participants were randomized to receive two daily dosing of 800 mg EIDD-2801 capsules (fasted). Total of all reporting groups
Overall Number of Baseline Participants 16 6 6 6 6 6 6 6 6 10 14 6 6 6 6 6 6 6 130
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 14 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 130 participants
39.4
(22 to 56)
52.0
(34 to 57)
41.2
(23 to 58)
39.8
(26 to 60)
42.0
(23 to 57)
38.2
(21 to 57)
39.5
(23 to 56)
34.2
(24 to 56)
30.8
(25 to 46)
45.3
(30 to 60)
37.5
(19 to 59)
34.0
(23 to 56)
45.5
(20 to 58)
36.8
(22 to 60)
36.2
(20 to 58)
38.8
(20 to 60)
30.8
(20 to 54)
30.8
(20 to 58)
38.7
(19 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 14 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 130 participants
Female
2
  12.5%
2
  33.3%
2
  33.3%
1
  16.7%
2
  33.3%
2
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
3
  30.0%
2
  14.3%
1
  16.7%
1
  16.7%
0
   0.0%
2
  33.3%
1
  16.7%
0
   0.0%
0
   0.0%
21
  16.2%
Male
14
  87.5%
4
  66.7%
4
  66.7%
5
  83.3%
4
  66.7%
4
  66.7%
6
 100.0%
6
 100.0%
6
 100.0%
7
  70.0%
12
  85.7%
5
  83.3%
5
  83.3%
6
 100.0%
4
  66.7%
5
  83.3%
6
 100.0%
6
 100.0%
109
  83.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 14 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 130 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
4
   3.1%
White
16
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
5
  83.3%
6
 100.0%
5
  83.3%
6
 100.0%
5
  83.3%
9
  90.0%
13
  92.9%
6
 100.0%
6
 100.0%
5
  83.3%
5
  83.3%
6
 100.0%
6
 100.0%
5
  83.3%
122
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
1
   7.1%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
4
   3.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 16 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 14 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 130 participants
24.80  (2.217) 26.07  (2.649) 23.50  (3.501) 26.68  (2.320) 24.48  (2.349) 25.32  (1.847) 26.45  (2.745) 25.15  (1.623) 23.37  (2.954) 25.38  (2.185) 24.79  (2.681) 22.27  (3.371) 24.97  (4.162) 25.50  (3.117) 24.48  (1.901) 24.32  (2.866) 24.50  (3.679) 24.20  (2.504) 24.81  (2.707)
1.Primary Outcome
Title Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events
Hide Description Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following a single dose of EIDD-2801 in Part 1
Time Frame From screening through study completion, up to 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Part 1 - Placebo Part 1 - 50 mg EIDD-2801 Part 1 - 100 mg EIDD-2801 Part 1 - 200 mg EIDD-2801 Part 1 - 400 mg EIDD-2801 Part 1 - 600 mg EIDD-2801 Part 1 - 800 mg EIDD-2801 Part 1 - 1200 mg EIDD-2801 Part 1 - 1600 mg EIDD-2801
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of Placebo (fasted).
Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).
Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).
Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).
Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).
Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).
Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).
Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).
Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).
Overall Number of Participants Analyzed 16 6 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs (Overall)
7
  43.8%
2
  33.3%
0
   0.0%
3
  50.0%
3
  50.0%
4
  66.7%
2
  33.3%
1
  16.7%
2
  33.3%
Mild (Grade 1)
7
  43.8%
2
  33.3%
0
   0.0%
3
  50.0%
3
  50.0%
4
  66.7%
2
  33.3%
1
  16.7%
2
  33.3%
Moderate (Grade 2)
1
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe (Grade 3)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events
Hide Description Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following multiple doses of EIDD-2801 in Part 3
Time Frame From screening through study completion, up to 20 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Part 3 - Placebo Part 3 - 50 mg EIDD-2801 Part 3 - 100 mg EIDD-2801 Part 3 - 200 mg EIDD-2801 Part 3 - 300 mg EIDD-2801 Part 3 - 400 mg EIDD-2801 Part 3 - 600 mg EIDD-2801 Part 3 - 800 mg EIDD-2801
Hide Arm/Group Description:
Participants were randomized to receive twice daily dosing of Placebo capsules (fasted).
Participants were randomized to receive twice daily dosing of 50 mg EIDD-2801 capsules (fasted).
Participants were randomized to receive twice daily dosing of 100 mg EIDD-2801 capsules (fasted).
Participants were randomized to receive twice daily dosing of 200 mg EIDD-2801 capsules (fasted).
Participants were randomized to receive twice daily dosing of 300 mg EIDD-2801 capsules (fasted).
Participants were randomized to receive twice daily dosing of 400 mg EIDD-2801 capsules (fasted).
Participants were randomized to receive twice daily dosing of 600 mg EIDD-2801 capsules (fasted).
Participants were randomized to receive twice daily dosing of 800 mg EIDD-2801 capsules (fasted).
Overall Number of Participants Analyzed 14 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs (Overall)
7
  50.0%
2
  33.3%
3
  50.0%
3
  50.0%
2
  33.3%
3
  50.0%
2
  33.3%
3
  50.0%
Mild (Grade 1)
7
  50.0%
2
  33.3%
3
  50.0%
3
  50.0%
2
  33.3%
3
  50.0%
2
  33.3%
3
  50.0%
Moderate (Grade 2)
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe (Grade 3)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days)
Adverse Event Reporting Description

Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events.

Open-ended questions may have been used to obtain this information.

 
Arm/Group Title Part 1 - Placebo Part 1 - 50 mg EIDD-2801 Part 1 - 100 mg EIDD-2801 Part 1 - 200 mg EIDD-2801 Part 1 - 400 mg EIDD-2801 Part 1 - 600 mg EIDD-2801 Part 1 - 800 mg EIDD-2801 Part 1 - 1200 mg EIDD-2801 Part 1 - 1600 mg EIDD-2801 Part 2 - 200 mg EIDD-2801 (Fasted) Part 2 - 200 mg EIDD-2801 (Fed) Part 3 - Placebo Part 3 - 50 mg EIDD-2801 Part 3 - 100 mg EIDD-2801 Part 3 - 200 mg EIDD-2801 Part 3 - 300 mg EIDD-2801 Part 3 - 400 mg EIDD-2801 Part 3 - 600 mg EIDD-2801 Part 3 - 800 mg EIDD-2801
Hide Arm/Group Description Participants were randomized to receive a single oral dose of Placebo (fasted). Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted). Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fed). Participants were randomized to receive twice daily dosing of Placebo capsules (fasted). Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted). Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted).
All-Cause Mortality
Part 1 - Placebo Part 1 - 50 mg EIDD-2801 Part 1 - 100 mg EIDD-2801 Part 1 - 200 mg EIDD-2801 Part 1 - 400 mg EIDD-2801 Part 1 - 600 mg EIDD-2801 Part 1 - 800 mg EIDD-2801 Part 1 - 1200 mg EIDD-2801 Part 1 - 1600 mg EIDD-2801 Part 2 - 200 mg EIDD-2801 (Fasted) Part 2 - 200 mg EIDD-2801 (Fed) Part 3 - Placebo Part 3 - 50 mg EIDD-2801 Part 3 - 100 mg EIDD-2801 Part 3 - 200 mg EIDD-2801 Part 3 - 300 mg EIDD-2801 Part 3 - 400 mg EIDD-2801 Part 3 - 600 mg EIDD-2801 Part 3 - 800 mg EIDD-2801
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/14 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Part 1 - Placebo Part 1 - 50 mg EIDD-2801 Part 1 - 100 mg EIDD-2801 Part 1 - 200 mg EIDD-2801 Part 1 - 400 mg EIDD-2801 Part 1 - 600 mg EIDD-2801 Part 1 - 800 mg EIDD-2801 Part 1 - 1200 mg EIDD-2801 Part 1 - 1600 mg EIDD-2801 Part 2 - 200 mg EIDD-2801 (Fasted) Part 2 - 200 mg EIDD-2801 (Fed) Part 3 - Placebo Part 3 - 50 mg EIDD-2801 Part 3 - 100 mg EIDD-2801 Part 3 - 200 mg EIDD-2801 Part 3 - 300 mg EIDD-2801 Part 3 - 400 mg EIDD-2801 Part 3 - 600 mg EIDD-2801 Part 3 - 800 mg EIDD-2801
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/14 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1 - Placebo Part 1 - 50 mg EIDD-2801 Part 1 - 100 mg EIDD-2801 Part 1 - 200 mg EIDD-2801 Part 1 - 400 mg EIDD-2801 Part 1 - 600 mg EIDD-2801 Part 1 - 800 mg EIDD-2801 Part 1 - 1200 mg EIDD-2801 Part 1 - 1600 mg EIDD-2801 Part 2 - 200 mg EIDD-2801 (Fasted) Part 2 - 200 mg EIDD-2801 (Fed) Part 3 - Placebo Part 3 - 50 mg EIDD-2801 Part 3 - 100 mg EIDD-2801 Part 3 - 200 mg EIDD-2801 Part 3 - 300 mg EIDD-2801 Part 3 - 400 mg EIDD-2801 Part 3 - 600 mg EIDD-2801 Part 3 - 800 mg EIDD-2801
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/16 (43.75%)   2/6 (33.33%)   0/6 (0.00%)   3/6 (50.00%)   3/6 (50.00%)   4/6 (66.67%)   2/6 (33.33%)   1/6 (16.67%)   2/6 (33.33%)   2/10 (20.00%)   1/10 (10.00%)   7/14 (50.00%)   2/6 (33.33%)   3/6 (50.00%)   3/6 (50.00%)   2/6 (33.33%)   3/6 (50.00%)   2/6 (33.33%)   3/6 (50.00%) 
Blood and lymphatic system disorders                                       
Lymphadenopathy  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders                                       
Ear pain  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Tinnitus  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders                                       
Abnormal sensation in eye  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye irritation  1  0/16 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Ocular hyperaemia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders                                       
Abdominal pain  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Abdominal pain upper  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Constipation  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Gastrointestinal sounds abnormal  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Mouth ulceration  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nausea  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vomiting  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders                                       
Catheter site dryness  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Catheter site pain  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Catheter site rash  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Feeling hot  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Influenza like illness  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Medical device site erythema  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Medical device site reaction  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Pyrexia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations                                       
Nasopharyngitis  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications                                       
Arthropod bite  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Wound  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders                                       
Arthralgia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Back pain  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pain in extremity  1  1/16 (6.25%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders                                       
Ageusia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dizziness  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dizziness postural  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Headache  1  3/16 (18.75%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypersomnia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypoaesthesia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Paraesthesia  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Parosmia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Poor quality sleep  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Presyncope  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Somnolence  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  2/14 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Taste disorder  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders                                       
Abnormal dreams  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Insomnia  1  0/16 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Renal and urinary disorders                                       
Chromaturia  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Pollakiuria  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders                                       
Vaginal haemorrhage  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                                       
Cough  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Epistaxis  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Oropharyngeal pain  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Rhinorrhoea  1  1/16 (6.25%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders                                       
Acne  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pruritus  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Rash  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Scab  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders                                       
Hot flush  1  0/16 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI is required to obtain written consent from the Sponsor before anything relating to the study can be published.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Wendy Painter
Organization: Ridgeback Biotherapeutics
Phone: 786-687-2495
EMail: EIDD2801@ridgebackbio.com
Layout table for additonal information
Responsible Party: Ridgeback Biotherapeutics, LP
ClinicalTrials.gov Identifier: NCT04392219    
Other Study ID Numbers: EIDD-2801-1001
2020-001407-17 ( EudraCT Number )
First Submitted: April 29, 2020
First Posted: May 18, 2020
Results First Submitted: June 15, 2021
Results First Posted: July 19, 2021
Last Update Posted: July 19, 2021