- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479631
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196
March 2, 2023 updated by: Brii Biosciences Limited
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
BRII-196 dose level 1 or placebo
|
Placebo given intravenously
BRII-196 given intravenously
|
Experimental: Cohort 2
BRII-196 dose level 2 or placebo
|
Placebo given intravenously
BRII-196 given intravenously
|
Experimental: Cohort 3
BRII-196 dose level 3 or placebo
|
Placebo given intravenously
BRII-196 given intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events (AEs) by CTCAE v5.0
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Proportion of subjects with SAEs
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Proportion of subjects with infusion-related reactions
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Proportion of subjects with hypersensitivity reactions
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum Concentration of BRII-196
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Yao Zhang, TSB Therapeutics (Beijing) CO.LTD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2020
Primary Completion (Actual)
January 29, 2021
Study Completion (Actual)
January 29, 2021
Study Registration Dates
First Submitted
July 14, 2020
First Submitted That Met QC Criteria
July 20, 2020
First Posted (Actual)
July 21, 2020
Study Record Updates
Last Update Posted (Estimate)
March 3, 2023
Last Update Submitted That Met QC Criteria
March 2, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRII-196-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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