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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: BRII-196 and BRII-198; Drug: Placebo

• Registration Number: NCT04691180
• Lead Sponsor: Brii Biosciences Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Study Start: 2021-01-05
• Primary Completion: 2021-09-16
• Study Completion: 2021-09-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	BRII-196 and BRII-198	BRII-196 and BRII-198 dose level 1 or placebo
Cohort 1	Placebo	BRII-196 and BRII-198 dose level 1 or placebo
Cohort 2	BRII-196 and BRII-198	BRII-196 and BRII-198 dose level 2 or placebo
Cohort 2	Placebo	BRII-196 and BRII-198 dose level 2 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

Secondary Outcome Measures

Name	Time	Method
Mean of change from pre-dose baseline in RBC count	up to 24 weeks
Mean of change from pre-dose baseline in WBC count.	up to 24 weeks
Proportion of subjects with hypersensitivity reactions	up to 24 weeks
Serum Concentration of BRII-196 and BRII-198	up to 24 weeks
Proportion of subjects with infusion-related reactions	up to 24 weeks
Mean of change from pre-dose baseline in ECG readings	up to 24 weeks	ECG readings include PR interval, RR interval, QRS interval, etc.
Mean of change from pre-dose baseline in Platelets count	up to 24 weeks
Mean of change from pre-dose baseline in Hemoglobin result	up to 24 weeks

Trial Locations

Locations (1)

Investigative Site; 🇨🇳 Beijing, Beijing, China