This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
SHR-6934 injection
SHR-6934 placebo
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Incidence of subjects with adverse events (AEs)
Time frame: Baseline up to 113 days after the last dosing
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Maximum plasma concentration (Cmax) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Time to reach maximum plasma concentration (Tmax) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Terminal half-life (t1/2) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously
Time frame: Baseline up to 113 days after the last dosing
Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously
Time frame: Baseline up to 113 days after the last dosing
Proportion of anti-drug antibodies (ADA) positive subjects
Time frame: Baseline up to 113 days after the last dosing
Baseline and placebo-adjusted QTcF after SHR-6934
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline up to 15 days after dosing