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

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    BRII-196 ...
  • Study Participants

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
Primary Completion
Jan 29
Study Completion
Jan 29
Last Update
Mar 02

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


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