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Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196

Sponsor
Brii Biosciences Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04479631
Collaborator
TSB Therapeutics (Beijing) CO.LTD (Industry)
16
Enrollment
1
Location
3
Arms
6.6
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 12, 2020
Actual Primary Completion Date :
Jan 29, 2021
Actual Study Completion Date :
Jan 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

BRII-196 dose level 1 or placebo

Drug: BRII-196
BRII-196 given intravenously

Drug: Placebo
Placebo given intravenously
Experimental: Cohort 2

BRII-196 dose level 2 or placebo

Drug: BRII-196
BRII-196 given intravenously

Drug: Placebo
Placebo given intravenously
Experimental: Cohort 3

BRII-196 dose level 3 or placebo

Drug: BRII-196
BRII-196 given intravenously

Drug: Placebo
Placebo given intravenously

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events (AEs) by CTCAE v5.0 [up to 24 weeks]

  2. Proportion of subjects with SAEs [up to 24 weeks]

  3. Proportion of subjects with infusion-related reactions [up to 24 weeks]

  4. Proportion of subjects with hypersensitivity reactions [up to 24 weeks]

Secondary Outcome Measures

  1. Serum Concentration of BRII-196 [up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigative Site Beijing Beijing China

Sponsors and Collaborators

  • Brii Biosciences Limited
  • TSB Therapeutics (Beijing) CO.LTD

Investigators

  • Study Director: Yao Zhang, TSB Therapeutics (Beijing) CO.LTD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brii Biosciences Limited
ClinicalTrials.gov Identifier:
NCT04479631
Other Study ID Numbers:
  • BRII-196-001
First Posted:
Jul 21, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brii Biosciences Limited
COVID-19 phase I
monoclonal antibody
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Mar 2, 2022