The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Guangzhou, Guangdong, China
Maximum Observed Serum Concentration (Cmax)
Time frame: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Time frame: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
Time frame: Predose and at multiple timepoints (up to 105 days) after dosing
Number of Participants with Treatment-emergent Adverse Events
Time frame: Day 1 through Day 105
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Physical Examinations
Time frame: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Electrocardiograms
Time frame: Screening (Days -28 to -1) through Day 105
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