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

Sponsor
Brii Biosciences Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04691180
Collaborator
TSB Therapeutics (Beijing) CO.LTD (Industry)
12
Enrollment
1
Location
2
Arms
8.3
Actual Duration (Months)
1.4
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/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.

Condition or Disease Intervention/Treatment Phase
  • Drug: BRII-196 and BRII-198
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 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 Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers
Actual Study Start Date :
Jan 5, 2021
Actual Primary Completion Date :
Sep 16, 2021
Actual Study Completion Date :
Sep 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

BRII-196 and BRII-198 dose level 1 or placebo

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

Drug: Placebo
Placebo given intravenously
Experimental: Cohort 2

BRII-196 and BRII-198 dose level 2 or placebo

Drug: BRII-196 and BRII-198
BRII-196 and BRII-198 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]

Secondary Outcome Measures

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

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

  3. Mean of change from pre-dose baseline in ECG readings [up to 24 weeks]

    ECG readings include PR interval, RR interval, QRS interval, etc.

  4. Mean of change from pre-dose baseline in WBC count. [up to 24 weeks]

  5. Mean of change from pre-dose baseline in RBC count [up to 24 weeks]

  6. Mean of change from pre-dose baseline in Platelets count [up to 24 weeks]

  7. Mean of change from pre-dose baseline in Hemoglobin result [up to 24 weeks]

  8. Serum Concentration of BRII-196 and BRII-198 [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:

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigative Site Beijing Beijing China 100015

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:
NCT04691180
Other Study ID Numbers:
  • BRII-196-198-001
First Posted:
Dec 31, 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