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Trial record 1 of 3 for:    EIDD-2801
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COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392219
Recruitment Status : Completed
First Posted : May 18, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ridgeback Biotherapeutics, LP

Brief Summary:
This is a First In Human study designed to assess the safety, tolerability and pharmacokinetics of EIDD-2801 in healthy human volunteers.

Condition or disease Intervention/treatment Phase
Coronavirus Drug: EIDD-2801 Drug: Placebo Phase 1

Detailed Description:
This is a randomized, double-blind, placebo-controlled, First-in-Human study designed to evaluate the safety, tolerability, and pharmacokinetics of EIDD-2801 following oral administration to healthy volunteers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of EIDD-2801 Following Oral Administration to Healthy Volunteers
Actual Study Start Date : April 10, 2020
Actual Primary Completion Date : August 11, 2020
Actual Study Completion Date : August 11, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EIDD-2801 Drug: EIDD-2801

Part 1:

Subjects will be randomized to receive a single oral dose of EIDD-2801 or Placebo.

Part 2:

Two single oral doses of EIDD-2801 will be administered to subjects, in an open-label manner.

Part 3:

Subjects will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.


Placebo Comparator: Placebo Drug: Placebo

Part 1:

Subjects will be randomized to receive a single oral dose of EIDD-2801 or Placebo.

Part 3:

Subjects will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.





Primary Outcome Measures :
  1. Safety and Tolerability of Single Ascending Dose (SAD) of EIDD-2801 (Part 1): Adverse Events [ Time Frame: From screening through study completion, up to 15 days ]
    Number and severity of treatment emergent adverse events

  2. Safety and Tolerability of Multiple Ascending Dose (MAD) of EIDD-2801 (Part 3): Adverse Events [ Time Frame: From screening through study completion, up to 20 days ]
    Number and severity of treatment emergent adverse events

  3. Pharmacokinetics (PK) of EIDD-2801 when given as Single Doses (Part 2): Maximum observed concentration Cmax [ Time Frame: Day 1 through Day 18 ]
    Multiple pharmacokinetic variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of EIDD-2801 when given as Single Ascending Dose (SAD) (Part 1): Maximum observed concentration Cmax [ Time Frame: Day 1 up to Day 4 ]
    Multiple PK variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax

  2. Pharmacokinetics (PK) of EIDD-2801 when given as Multiple Ascending Dose (MAD) (Part 3): Maximum observed concentration Cmax [ Time Frame: Day 1 up to Day 14 ]
    Multiple PK variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax

  3. Safety and Tolerability of Single Doses of EIDD-2801 (Part 2): Adverse Events [ Time Frame: From screening through study completion, up to 30 days ]
    Number and severity of treatment emergent adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between the ages of 18 and 60, inclusive.
  • Female subjects must be of non-childbearing potential.
  • Male participants must agree to the use of effective contraception for study duration
  • Is in generally good health as determined by medical history, physical examinations (PEs) (at Screening and/or Check-in), vital signs, and other screening procedures.
  • Has a body mass index (BMI) of 18 to 30 kg/m2.

Exclusion Criteria:

  • Females who are pregnant, planning to become pregnant, or breastfeeding.
  • Has a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal (GI), hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as determined by the principal investigator (PI) (or designee).
  • Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
  • Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias.
  • Has a history of gastrointestinal (GI) surgery or other condition that may interfere with absorption of study drug, in the opinion of the principal investigator (PI) (or designee).
  • Has a history of febrile illness within the 14 days prior to the first dose of study drug.
  • Has a positive alcohol or drug screen at Screening or the Day -1 visit or has a history of alcohol or drug abuse within the past 5 years.
  • Currently uses tobacco, nicotine or tobacco products or e-cigarettes, or stopped using tobacco products within the past 3 months
  • Has a total white cell count or absolute lymphocyte count outside the normal range, or hemoglobin or platelet levels below the lower limit of normal, at Screening or Day -1.
  • Has values above the upper limit of normal for the following laboratory analytes: alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase (serum), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), at Screening or Day -1.
  • Positive test result for human immunodeficiency virus (HIV), hepatitis b virus (HBV), or hepatitis c virus (HCV).
  • Has an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
  • Has any of the following:

    • QT interval corrected for heart rate (using Fridericia's formula) (QTcF) >450 ms confirmed by repeat measurement
    • QRS duration >110 ms confirmed by repeat measurement
    • PR interval >220 ms confirmed by repeat measurements
    • findings which would make QTc measurements difficult or QTc data uninterpretable
    • history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
  • Except as noted, has used prescription drugs (other than hormone replacement therapy) within 14 days prior to the first dose of study drug unless, in the opinion of the PI (or designee), the drug will not interfere with study assessments.
  • Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 3 months prior to the first dose of study drug and agrees not to receive another experimental agent during the duration of this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392219


Locations
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United Kingdom
Covance Leeds Clinical Research Unit
Leeds, United Kingdom
Sponsors and Collaborators
Ridgeback Biotherapeutics, LP
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Responsible Party: Ridgeback Biotherapeutics, LP
ClinicalTrials.gov Identifier: NCT04392219    
Other Study ID Numbers: EIDD-2801-1001
2020-001407-17 ( EudraCT Number )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ridgeback Biotherapeutics, LP:
Coronavirus
EIDD-2801
ribonucleoside
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases