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

Brii Biosciences

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: BRII-198

Study type: Interventional

Funder types: Industry

Identifiers

NCT04479644

BRII-198-001

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 3 patient groups

Cohort 1

Experimental group

Description:

BRII-198 dose level 1 or placebo

Treatment:

Drug: BRII-198

Drug: Placebo

Cohort 2

Experimental group

Description:

BRII-198 dose level 2 or placebo

Treatment:

Drug: BRII-198

Drug: Placebo

Cohort 3

Experimental group

Description:

BRII-198 dose level 3 or placebo

Treatment:

Drug: BRII-198

Drug: Placebo