A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

Brii Biosciences

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Drug: BRII-196 and BRII-198; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04691180

BRII-196-198-001

Details and patient eligibility

About

This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.

Enrollment: 12 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject must be 18 to 49 years of age inclusive
2. Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-26.0kg/m2 (inclusive).
3. Male or female

Exclusion criteria

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation.
2. A history of significant hypersensitivity, intolerance, or allergy to any drug compound
3. 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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12 participants in 2 patient groups

Cohort 1

Experimental group

Description:

BRII-196 and BRII-198 dose level 1 or placebo

Treatment:

Drug: Placebo

Drug: BRII-196 and BRII-198

Cohort 2

Experimental group

Description:

BRII-196 and BRII-198 dose level 2 or placebo

Treatment:

Drug: Placebo

Drug: BRII-196 and BRII-198