A Pharmacokinetic Study of JS002 in Healthy Subjects

Summary

This study was a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. Subjects were randomly assigned to 1 of 2 parallel treatment groups: treatment group A received a single subcutaneous injection of JS002 150 mg via PFS, and treatment group B received a single subcutaneous injection of JS002 150 mg via AI. Subjects were followed up to study day 85 for pharmacokinetic equivalence assessment of JS002. A total of 159 subjects were planned to be included in each group. After signing the informed consent form and completing the screening examination, subjects will be randomly assigned to treatment arm A or treatment arm B if eligible for inclusion. The study period consisted of a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects were admitted to the phase I clinical research unit the day before dose administration (day 1) and were not allowed to leave until all examinations and assessments were completed on day 6 after dose administration and were allowed to return to the clinical research center for follow-up visits on days 8,11,15,22,29,43,57,71, and 85.

Timeline

Start

2023-05-30

Primary completion

2023-06-30

Completion

2023-09-11

Drugs

Indications

No indication recorded.