A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
A single subcutaneous injection of Dose1 SHR-7012 injection or placebo was administered
A single subcutaneous injection of Dose2 SHR-7012 injection or placebo was administered
A single subcutaneous injection of Dose3 SHR-7012 injection or placebo was administered
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGSafety and tolerability : Incidence and severity of any adverse events
Time frame: Evaluation was performed up to Day141
AUC0-t
Time frame: Evaluation was performed up to Day113 or Day141
AUC0 ∞
Time frame: Evaluation was performed up to Day113 or Day141
Tmax
Time frame: Evaluation was performed up to Day113 or Day141
Cmax
Time frame: Evaluation was performed up to Day113 or Day141
t1/2
Time frame: Evaluation was performed up to Day113 or Day141
λz
Time frame: Evaluation was performed up to Day113 or Day141
CL/F
Time frame: Evaluation was performed up to Day113 or Day141.
Vz/F
Time frame: Evaluation was performed up to Day113 or Day141.
MRT0-t
Time frame: Evaluation was performed up to Day113 or Day141.
MRT0-∞
Time frame: Evaluation was performed up to Day113 or Day141.
AUC%Extrap
Time frame: Evaluation was performed up to Day113 or Day141.
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A single subcutaneous injection of Dose4 SHR-7012 injection or placebo was administered
A single subcutaneous injection of Dose5 SHR-7012 injection or placebo was administered
Antidrug antibody (ADA)
Time frame: Evaluation was performed up to Day113 or Day141.
Neutralizing antibody (NAb)
Time frame: Evaluation was performed up to Day113 or Day141.