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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2021-02-03

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cohort 1

BRII-198 dose level 1 or placebo

Group Type EXPERIMENTAL

BRII-198

Intervention Type DRUG

BRII-198 given intravenously

Placebo

Intervention Type DRUG

Placebo given intravenously

Cohort 2

BRII-198 dose level 2 or placebo

Group Type EXPERIMENTAL

BRII-198

Intervention Type DRUG

BRII-198 given intravenously

Placebo

Intervention Type DRUG

Placebo given intravenously

Cohort 3

BRII-198 dose level 3 or placebo

Group Type EXPERIMENTAL

BRII-198

Intervention Type DRUG

BRII-198 given intravenously

Placebo

Intervention Type DRUG

Placebo given intravenously

Interventions

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BRII-198

BRII-198 given intravenously

Intervention Type DRUG

Placebo

Placebo given intravenously

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes