Trial Outcomes & Findings for A Study of OsrHSA in Adult Healthy Male and Female Volunteers (NCT NCT04384523)
NCT ID: NCT04384523
Last Updated: 2021-06-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
from date of Informed Consent through Day 30 (Study Completion)
Results posted on
2021-06-01
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Normal Saline (0.9% Sodium Chloride)
|
OsrHSA 20 mg/kg IV
OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 40 mg/kg IV
OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 80 mg/kg IV
OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 140 mg/kg IV
OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 200 mg/kg IV
OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
9
|
5
|
6
|
6
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Normal Saline (0.9% Sodium Chloride)
|
OsrHSA 20 mg/kg IV
OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 40 mg/kg IV
OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 80 mg/kg IV
OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 140 mg/kg IV
OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 200 mg/kg IV
OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of OsrHSA in Adult Healthy Male and Female Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo: Normal Saline (0.9% Sodium Chloride)
|
OsrHSA 20 mg/kg IV
n=6 Participants
OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 40 mg/kg IV
n=6 Participants
OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 80 mg/kg IV
n=6 Participants
OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 140 mg/kg IV
n=7 Participants
OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 200 mg/kg IV
n=6 Participants
OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.0 years
n=99 Participants
|
34.5 years
n=107 Participants
|
33.5 years
n=206 Participants
|
34.0 years
n=7 Participants
|
37.0 years
n=31 Participants
|
35.5 years
n=30 Participants
|
35.0 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
23 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
32 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Weight
|
62.5 Kilograms
n=99 Participants
|
67.2 Kilograms
n=107 Participants
|
69.4 Kilograms
n=206 Participants
|
71.6 Kilograms
n=7 Participants
|
83 Kilograms
n=31 Participants
|
68.1 Kilograms
n=30 Participants
|
67.3 Kilograms
n=3 Participants
|
|
Height
|
167.5 Centimeter
n=99 Participants
|
169.0 Centimeter
n=107 Participants
|
161.4 Centimeter
n=206 Participants
|
171.8 Centimeter
n=7 Participants
|
171.1 Centimeter
n=31 Participants
|
165.8 Centimeter
n=30 Participants
|
169.1 Centimeter
n=3 Participants
|
|
BMI
|
21.4 kg/m2
n=99 Participants
|
23.6 kg/m2
n=107 Participants
|
25.8 kg/m2
n=206 Participants
|
24.8 kg/m2
n=7 Participants
|
28.4 kg/m2
n=31 Participants
|
22.8 kg/m2
n=30 Participants
|
23.6 kg/m2
n=3 Participants
|
PRIMARY outcome
Timeframe: from date of Informed Consent through Day 30 (Study Completion)Outcome measures
| Measure |
Placebo
n=10 Participants
Normal Saline (0.9% Sodium Chloride)
|
OsrHSA 20 mg/kg IV
n=6 Participants
A single dose of OsrHSA 20 mg/kg IV
|
OsrHSA 40 mg/kg IV
n=6 Participants
A single dose of OsrHSA 40 mg/kg IV
|
OsrHSA 80 mg/kg IV
n=6 Participants
A single dose of OsrHSA 80 mg/kg IV
|
OsrHSA 140 mg/kg IV
n=7 Participants
A single dose of OsrHSA 140 mg/kg IV
|
OsrHSA 200 mg/kg IV
n=6 Participants
A single dose of OsrHSA 200 mg/kg IV
|
|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: pre-dose, 0.5 hours after dose initiating, EOI (End of Infusion), and 0.5 hours, 4 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), Day 5, Day 8, Day 15, Day 22, and Day 30 post End of Infusion.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-dose, Day 8, Day 15, Day 22, and Day 30 post End of InfusionOutcome measures
| Measure |
Placebo
n=10 Participants
Normal Saline (0.9% Sodium Chloride)
|
OsrHSA 20 mg/kg IV
n=6 Participants
A single dose of OsrHSA 20 mg/kg IV
|
OsrHSA 40 mg/kg IV
n=6 Participants
A single dose of OsrHSA 40 mg/kg IV
|
OsrHSA 80 mg/kg IV
n=6 Participants
A single dose of OsrHSA 80 mg/kg IV
|
OsrHSA 140 mg/kg IV
n=7 Participants
A single dose of OsrHSA 140 mg/kg IV
|
OsrHSA 200 mg/kg IV
n=6 Participants
A single dose of OsrHSA 200 mg/kg IV
|
|---|---|---|---|---|---|---|
|
Number of Participants With ADA Incident Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
OsrHSA 20 mg/kg IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OsrHSA 40 mg/kg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OsrHSA 80 mg/kg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
OsrHSA 140 mg/kg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OsrHSA 200 mg/kg IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo: Normal Saline (0.9% Sodium Chloride)
|
OsrHSA 20 mg/kg IV
n=6 participants at risk
OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 40 mg/kg IV
n=6 participants at risk
OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 80 mg/kg IV
n=6 participants at risk
OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 140 mg/kg IV
n=7 participants at risk
OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
|
OsrHSA 200 mg/kg IV
n=6 participants at risk
OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/10 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
16.7%
1/6 • Number of events 1 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
0.00%
0/7 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
16.7%
1/6 • Number of events 1 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
14.3%
1/7 • Number of events 1 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
0.00%
0/7 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/10 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
14.3%
1/7 • Number of events 1 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
16.7%
1/6 • Number of events 1 • Screening to Day 30 +/- 2 days
|
0.00%
0/7 • Screening to Day 30 +/- 2 days
|
0.00%
0/6 • Screening to Day 30 +/- 2 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place