COVID-19
Conditions
Keywords
COVID-19 phase I, monoclonal antibody
Brief summary
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.
Interventions
BRII-196 and BRII-198 given intravenously
DRUGPlacebo
Placebo given intravenously
Sponsors
TSB Therapeutics (Beijing) CO.LTD
Brii Biosciences Limited
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
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
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of change from pre-dose baseline in ECG readings | up to 24 weeks | ECG readings include PR interval, RR interval, QRS interval, etc. |
| 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 | — |
| Proportion of subjects with infusion-related reactions | 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 | — |
| Mean of change from pre-dose baseline in Platelets count | up to 24 weeks | — |
| Proportion of subjects with hypersensitivity reactions | up to 24 weeks | — |
Countries
China
Outcome results
None listed