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Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04479644
Recruitment Status : Completed
First Posted : July 21, 2020
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
TSB Therapeutics (Beijing) CO.LTD
Information provided by (Responsible Party):
Brii Biosciences Limited

Study Description
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Brief Summary:
This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: BRII-198 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 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-198 Administered Intravenously to Healthy Adult Volunteers
Actual Study Start Date : July 13, 2020
Actual Primary Completion Date : February 3, 2021
Actual Study Completion Date : February 3, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
BRII-198 dose level 1 or placebo
 Drug: BRII-198
BRII-198 given intravenously

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

Drug: Placebo
Placebo given intravenously
Experimental: Cohort 3
BRII-198 dose level 3 or placebo
 Drug: BRII-198
BRII-198 given intravenously

Drug: Placebo
Placebo given intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) by CTCAE v5.0 [ Time Frame: up to 24 weeks ]
  2. Proportion of subjects with SAEs [ Time Frame: up to 24 weeks ]
  3. Proportion of subjects with infusion-related reactions [ Time Frame: up to 24 weeks ]
  4. Proportion of subjects with hypersensitivity reactions [ Time Frame: up to 24 weeks ]

Secondary Outcome Measures :
  1. Serum Concentration of BRII-198 [ Time Frame: up to 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479644


Locations
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China, Beijing
Investigative Site
Beijing, Beijing, China
Sponsors and Collaborators
Brii Biosciences Limited
TSB Therapeutics (Beijing) CO.LTD
Investigators
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Study Director: Yao Zhang TSB Therapeutics (Beijing) CO.LTD
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brii Biosciences Limited
ClinicalTrials.gov Identifier: NCT04479644    
Other Study ID Numbers: BRII-198-001
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases