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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
BRII-196 and BRII-198 given intravenously
Placebo given intravenously
Investigative Site
Beijing, Beijing Municipality, China
Incidence of adverse events (AEs) by CTCAE v5.0
Time frame: up to 24 weeks
Proportion of subjects with SAEs
Time frame: up to 24 weeks
Proportion of subjects with infusion-related reactions
Time frame: up to 24 weeks
Proportion of subjects with hypersensitivity reactions
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in ECG readings
ECG readings include PR interval, RR interval, QRS interval, etc.
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in WBC count.
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in RBC count
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in Platelets count
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in Hemoglobin result
Time frame: up to 24 weeks
Serum Concentration of BRII-196 and BRII-198
Time frame: up to 24 weeks
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