Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198

• Status: Completed
• Trial end date: 2021-02-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1 study in which healthy adult volunteers will receive 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:

• Subject must be 18 to 49 years of age inclusive;

• Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive);

• Male or female;

Exclusion Criteria:

• 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;