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

This is a phase 1 study in which healthy adult volunteers will receive BRII-196 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.

Status
Completed
Conditions
COVID-19
Interventions

Drug: BRII-196

BRII-196 given intravenously

Drug: Placebo

Placebo given intravenously

Eligibility 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;

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
NCT04479631
Keywords
COVID-19 phase I
monoclonal antibody
MeSH Terms
COVID-19