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.
Aged 18-55 years at ICF signing.
Screening BMI 19-26 kg/m², weight 50-80 kg.
Normal or NCS findings at screening/baseline: physical exam, lab tests (CBC, blood chemistry, UA, coagulation), ECG, abdominal ultrasound, chest X-ray.
Investigator-assessed absence of diseases that could significantly impact the study or pose additional health risks; stable health expected, no medical intervention needed. Clinically significant lab abnormalities may be retested within 1 week if justified; retest results determine eligibility.
AST, ALT, or bilirubin > ULN at screening/baseline.
eGFR < 90 mL/min/1.73m² at screening/baseline.
Clinically significant abnormal blood pressure (SBP >140 or <90 mmHg; DBP >90 or <60 mmHg) at screening/baseline.
Positive for HBsAg, HBcAb with HBV-DNA > ULN, HIV-Ab, syphilis serology, or HCV-Ab at screening.
Parallel
SHR-1703 Injection
DrugA single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
SHR-1703 Injection
DrugA single subcutaneous dose of SHR-1703 Injection administered via autoinjector.
peak concentration (Cmax)
area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Tmax,
t1/2
CL/F,
Vz/F.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
