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A Clinical Study to Measure the Effect of OP-101 After Being Administered Subcutaneous 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: NCT04321980
Recruitment Status : Completed
First Posted : March 26, 2020
Results First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Orpheris, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: OP-101
Enrollment 8
Recruitment Details  
Pre-assignment Details A total of 8 participants were enrolled and treated in the study.
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description Participants in Cohort 1 received a single dose of 4 milligram per kg (mg/kg) OP-101 as subcutaneous (SC) injection on Day 1. Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
Period Title: Overall Study
Started 4 4
Completed 4 4
Not Completed 0 0
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg Total
Hide Arm/Group Description Participants in Cohort 1 received a single dose of 4 milligram per kg (mg/kg) OP-101 as subcutaneous (SC) injection on Day 1. Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
Analysis was performed on safety population which included all participants who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
8
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
3
  75.0%
4
 100.0%
7
  87.5%
Male
1
  25.0%
0
   0.0%
1
  12.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Hispanic or Latino
1
  25.0%
0
   0.0%
1
  12.5%
Not Hispanic or Latino
3
  75.0%
4
 100.0%
7
  87.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 4 participants 4 participants 8 participants
Asian
0
   0.0%
1
  25.0%
1
  12.5%
White
3
  75.0%
3
  75.0%
6
  75.0%
Filipino
1
  25.0%
0
   0.0%
1
  12.5%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. A TEAE (treatment-emergent adverse event) was defined as an AE that emerges, having been absent prior to the study, or an AE that worsens in severity after the first dose of the study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes: death; life-threatening adverse event, required hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, or a medically important event.
Time Frame Up to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population.
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description:
Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
Overall Number of Participants Analyzed 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
2
  50.0%
3
  75.0%
Any SAE
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of OP-101
Hide Description Cmax: maximum observed plasma concentration.
Time Frame Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on pharmacokinetic (PK) parameter population which was defined as all participants who received a dose of study drug and had at least 1 PK parameter.
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description:
Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter(mcg/mL)
3.473  (0.8183) 6.640  (0.6073)
3.Secondary Outcome
Title Pharmacokinetics: Time to Reach Maximum Plasma Concentration (Tmax) of OP-101
Hide Description Tmax: time to reach maximum observed plasma concentration.
Time Frame Pre-dose, 0.5 hours and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter population.
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description:
Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
Overall Number of Participants Analyzed 4 4
Median (Full Range)
Unit of Measure: hours
14.015
(10.00 to 16.05)
16.000
(12.00 to 24.05)
4.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of OP-101
Hide Description AUC0-last: Area under the concentration versus time curve from time zero to the last quantifiable concentration (Clast).
Time Frame Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter population.
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description:
Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: hr*mcg/mL
80.940  (51.8190) 212.325  (30.6459)
5.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to 48 Hour Post Dose Time Point (AUC0-48) of OP-101
Hide Description Area under the concentration versus time curve from time zero to 48 hour post dose time point.
Time Frame Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter population.
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description:
Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: hr*mcg/mL
121.705  (16.9069) 222.173  (12.4690)
6.Secondary Outcome
Title Pharmacokinetics: Renal Clearance (CLR) for OP-101
Hide Description CLR was defined as renal clearance of the drug from plasma utilizing the AUC and cumulative amount of unchanged study drug excreted into the urine (Ae) to the same duration (as Amount recovered/AUC at 0-48 hours).
Time Frame Pre-dose, 0 to 4, 4 to 8, 8 to 12, 12 to 18, 18 to 24, and 24 to 48 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description:
Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
Overall Number of Participants Analyzed 2 4
Mean (Standard Deviation)
Unit of Measure: liter per hour (L/hr)
0.175  (0.0354) 0.150  (0.0606)
Time Frame Up to Day 15
Adverse Event Reporting Description Analysis was performed on safety population.
 
Arm/Group Title Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Hide Arm/Group Description Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1. Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
All-Cause Mortality
Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: 4 mg/kg Cohort 2: 8 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   3/4 (75.00%) 
General disorders     
Injection site erythema † 1  0/4 (0.00%)  3/4 (75.00%) 
Injection site mass † 1  0/4 (0.00%)  1/4 (25.00%) 
Injection site pain † 1  1/4 (25.00%)  0/4 (0.00%) 
Injection site pallor † 1  1/4 (25.00%)  0/4 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea † 1  0/4 (0.00%)  1/4 (25.00%) 
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey L Cleland, PhD, Executive Chair
Organization: Orpheris, Inc.
Phone: 650-505-5048
EMail: cleland@orpheris.com
Layout table for additonal information
Responsible Party: Orpheris, Inc.
ClinicalTrials.gov Identifier: NCT04321980    
Other Study ID Numbers: OP-101-003
First Submitted: March 23, 2020
First Posted: March 26, 2020
Results First Submitted: March 31, 2021
Results First Posted: June 14, 2021
Last Update Posted: June 14, 2021