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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04479631

Enrollment

Registered

2020-07-21

Start date

2020-07-12

Completion date

2021-01-29

Last updated

2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19 phase I, monoclonal antibody

Brief 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.

Interventions

DRUGBRII-196

BRII-196 given intravenously

DRUGPlacebo

Placebo given intravenously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs) by CTCAE v5.0	up to 24 weeks
Proportion of subjects with SAEs	up to 24 weeks
Proportion of subjects with infusion-related reactions	up to 24 weeks
Proportion of subjects with hypersensitivity reactions	up to 24 weeks

Secondary

Measure	Time frame
Serum Concentration of BRII-196	up to 24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026