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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691180
• Other study ID #: BRII-196-198-001
• Status: Completed
• Phase: Phase 1
• Start date: January 5, 2021
• Est. completion date: September 16, 2021

Study information

• Verified date: March 2023
• Source: Brii Biosciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 16, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• BRII-196 and BRII-198
BRII-196 and BRII-198 given intravenously
• Placebo
Placebo given intravenously

Locations

Country	Name	City	State
China	Investigative Site	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Brii Biosciences Limited	TSB Therapeutics (Beijing) CO.LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) by CTCAE v5.0		up to 24 weeks
Primary	Proportion of subjects with SAEs		up to 24 weeks
Secondary	Proportion of subjects with infusion-related reactions		up to 24 weeks
Secondary	Proportion of subjects with hypersensitivity reactions		up to 24 weeks
Secondary	Mean of change from pre-dose baseline in ECG readings	ECG readings include PR interval, RR interval, QRS interval, etc.	up to 24 weeks
Secondary	Mean of change from pre-dose baseline in WBC count.		up to 24 weeks
Secondary	Mean of change from pre-dose baseline in RBC count		up to 24 weeks
Secondary	Mean of change from pre-dose baseline in Platelets count		up to 24 weeks
Secondary	Mean of change from pre-dose baseline in Hemoglobin result		up to 24 weeks
Secondary	Serum Concentration of BRII-196 and BRII-198		up to 24 weeks