A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brii Biosciences Limited
• Collaborator: TSB Therapeutics (Beijing) CO.LTD

Criteria

Inclusion Criteria:

1. Subject must be 18 to 49 years of age inclusive

2. Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-26.0kg/m2 (inclusive).

3. Male or female

Exclusion Criteria:

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation.

2. A history of significant hypersensitivity, intolerance, or allergy to any drug compound

3. History of alcohol or other substance abuse