Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: BRII-196; Drug: Placebo

• Registration Number: NCT04479631
• Lead Sponsor: Brii Biosciences Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-12
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Primary Completion: 2021-01-29
• Study Completion: 2021-01-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3	BRII-196	BRII-196 dose level 3 or placebo
Cohort 2	BRII-196	BRII-196 dose level 2 or placebo
Cohort 1	BRII-196	BRII-196 dose level 1 or placebo
Cohort 1	Placebo	BRII-196 dose level 1 or placebo
Cohort 2	Placebo	BRII-196 dose level 2 or placebo
Cohort 3	Placebo	BRII-196 dose level 3 or placebo

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) by CTCAE v5.0	up to 24 weeks
Proportion of subjects with SAEs	up to 24 weeks
Proportion of subjects with infusion-related reactions	up to 24 weeks
Proportion of subjects with hypersensitivity reactions	up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of BRII-196	up to 24 weeks

Trial Locations

Locations (1)

Investigative Site; 🇨🇳 Beijing, Beijing, China