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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers

Conditions
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COVID-19

Intervention / Treatment
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* Drug: BRII-196 and BRII-198
* Drug: Placebo


Participation Criteria
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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 19.0-26.0kg/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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>BRII-196 and BRII-198 dose level 1 or placebo | Drug: BRII-196 and BRII-198<br>* BRII-196 and BRII-198 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|
| Experimental: Cohort 2<br>BRII-196 and BRII-198 dose level 2 or placebo | Drug: BRII-196 and BRII-198<br>* BRII-196 and BRII-198 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) by CTCAE v5.0 |  | up to 24 weeks | 
| Proportion of subjects with SAEs |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with infusion-related reactions |  | up to 24 weeks | 
| Proportion of subjects with hypersensitivity reactions |  | up to 24 weeks | 
| Mean of change from pre-dose baseline in ECG readings | ECG readings include PR interval, RR interval, QRS interval, etc. | up to 24 weeks | 
| Mean of change from pre-dose baseline in WBC count. |  | up to 24 weeks | 
| Mean of change from pre-dose baseline in RBC count |  | up to 24 weeks | 
| Mean of change from pre-dose baseline in Platelets count |  | up to 24 weeks | 
| Mean of change from pre-dose baseline in Hemoglobin result |  | up to 24 weeks | 
| Serum Concentration of BRII-196 and BRII-198 |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 phase I, monoclonal antibody