Status:
COMPLETED
A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
Lead Sponsor:
Brii Biosciences Limited
Collaborating Sponsors:
TSB Therapeutics (Beijing) CO.LTD
Conditions:
COVID-19
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.
Eligibility Criteria
Inclusion
- Subject must be 18 to 49 years of age inclusive
- Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-26.0kg/m2 (inclusive).
- Male or female
Exclusion
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation.
- A history of significant hypersensitivity, intolerance, or allergy to any drug compound
- History of alcohol or other substance abuse
Key Trial Info
Start Date :
January 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04691180
Start Date
January 5 2021
End Date
September 16 2021
Last Update
March 3 2023
Active Locations (1)
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1
Investigative Site
Beijing, Beijing Municipality, China, 100015