Official Title
A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers
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.

Status
Completed
Conditions
COVID-19
Interventions

Drug: BRII-196 and BRII-198

BRII-196 and BRII-198 given intravenously

Drug: Placebo

Placebo given intravenously

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 49 Years
Countries
China
Locations

Investigative Site
Beijing, Beijing, China

Investigators

Yao Zhang, Study Director
TSB Therapeutics (Beijing) CO.LTD

Sponsors / Collaborators
TSB Therapeutics (Beijing) CO.LTD
NCT Number
NCT04691180
Keywords
COVID-19 phase I
monoclonal antibody
MeSH Terms
COVID-19