This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants. A total of 84 healthy participants are planned to be enrolled and randomized in a 1:1 ratio to either the PFS group or the AI group. Participants in the PFS group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled safety syringe, while participants in the AI group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled autoinjector.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.
The First Affiliated Hospital , Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
peak concentration (Cmax)
Time frame: Days 1-267
area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
Time frame: Days 1-267
area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Days 1-267
Tmax,
Time frame: Days 1-267
t1/2
Time frame: Days 1-267
CL/F,
Time frame: Days 1-267
Vz/F.
Time frame: Days 1-267
Safety and tolerability as assessed by the incidence and severity of AEs,
Time frame: Days 1-267
Immunogenicity of SHR-1703 as assessed by the presence and incidence of anti-drug antibodies (ADAs) and, if applicable, neutralizing antibodies (NAbs).
Time frame: Days 1-267
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