Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BRII-196
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 phase I, monoclonal antibody
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;
Sites / Locations
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
BRII-196 dose level 1 or placebo
BRII-196 dose level 2 or placebo
BRII-196 dose level 3 or placebo
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs) by CTCAE v5.0
Proportion of subjects with SAEs
Proportion of subjects with infusion-related reactions
Proportion of subjects with hypersensitivity reactions
Secondary Outcome Measures
Serum Concentration of BRII-196
Full Information
NCT ID
NCT04479631
First Posted
July 14, 2020
Last Updated
March 2, 2023
Sponsor
Brii Biosciences Limited
Collaborators
TSB Therapeutics (Beijing) CO.LTD
1. Study Identification
Unique Protocol Identification Number
NCT04479631
Brief Title
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2020 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
January 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brii Biosciences Limited
Collaborators
TSB Therapeutics (Beijing) CO.LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 phase I, monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
BRII-196 dose level 1 or placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
BRII-196 dose level 2 or placebo
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
BRII-196 dose level 3 or placebo
Intervention Type
Drug
Intervention Name(s)
BRII-196
Intervention Description
BRII-196 given intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given intravenously
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs) by CTCAE v5.0
Time Frame
up to 24 weeks
Title
Proportion of subjects with SAEs
Time Frame
up to 24 weeks
Title
Proportion of subjects with infusion-related reactions
Time Frame
up to 24 weeks
Title
Proportion of subjects with hypersensitivity reactions
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Serum Concentration of BRII-196
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yao Zhang
Organizational Affiliation
TSB Therapeutics (Beijing) CO.LTD
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36147329
Citation
Hao X, Zhang Z, Ma J, Cheng L, Ji Y, Liu Y, Zhao D, Zhang W, Li C, Yan L, Margolis D, Zhu Q, Zhang Y, Zhang F. Randomized, placebo-controlled, single-blind phase 1 studies of the safety, tolerability, and pharmacokinetics of BRII-196 and BRII-198, SARS-CoV-2 spike-targeting monoclonal antibodies with an extended half-life in healthy adults. Front Pharmacol. 2022 Sep 6;13:983505. doi: 10.3389/fphar.2022.983505. eCollection 2022.
Results Reference
derived
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
Learn more about this trial
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196
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