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

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 Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100015
        • 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:

  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 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 and BRII-198 dose level 1 or placebo
Drug: Placebo
Placebo given intravenously
Drug: BRII-196 and BRII-198
BRII-196 and BRII-198 given intravenously
Experimental: Cohort 2
BRII-196 and BRII-198 dose level 2 or placebo
Drug: Placebo
Placebo given intravenously
Drug: BRII-196 and BRII-198
BRII-196 and BRII-198 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Mean of change from pre-dose baseline in ECG readings
Time Frame: up to 24 weeks
ECG readings include PR interval, RR interval, QRS interval, etc.
up to 24 weeks
Mean of change from pre-dose baseline in WBC count.
Time Frame: up to 24 weeks
up to 24 weeks
Mean of change from pre-dose baseline in RBC count
Time Frame: up to 24 weeks
up to 24 weeks
Mean of change from pre-dose baseline in Platelets count
Time Frame: up to 24 weeks
up to 24 weeks
Mean of change from pre-dose baseline in Hemoglobin result
Time Frame: up to 24 weeks
up to 24 weeks
Serum Concentration of BRII-196 and BRII-198
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

Brii Biosciences Limited

Collaborators

TSB Therapeutics (Beijing) CO.LTD

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

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)

January 5, 2021

Primary Completion (Actual)

September 16, 2021

Study Completion (Actual)

September 16, 2021

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

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-196-198-001

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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