Trial | NCT04479631  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    BRII-196 ...

  • Study Participants

    16
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.
Study Started
Jul 12
2020
Primary Completion
Jan 29
2021
Study Completion
Jan 29
2021
Last Update
Mar 03
2023

Drug BRII-196

BRII-196 given intravenously

Drug Placebo

Placebo given intravenously

Cohort 1 Experimental

BRII-196 dose level 1 or placebo

Cohort 2 Experimental

BRII-196 dose level 2 or placebo

Cohort 3 Experimental

BRII-196 dose level 3 or placebo

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;
No Results Posted