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

  • STATUS
    Recruiting
  • participants needed
    12
  • sponsor
    Brii Biosciences Limited
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Updated on 16 February 2024
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body mass index
monoclonal antibodies

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.

Details
Condition Covid 19
Age 18years - 49years
Treatment Placebo, BRII-196
Clinical Study IdentifierNCT04479631
SponsorBrii Biosciences Limited
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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