NCT05859529

A Pharmacokinetic Study of JS002 in Healthy Subjects

A Single-center, Randomized, Open-label, Parallel-controlled Study Was Conducted to Compare the Pharmacokinetics of JS002 When Delivered Subcutaneously Via a Prefilled Syringe Versus a Prefilled Autosyringe in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health Volunteer

Interventions

Type	Name	Description
DRUG	JS002	The drug was administered by a single subcutaneous injection

Timeline

• Start date: 2023-05-30
• Primary completion: 2023-06-30
• Completion: 2023-09-11
• First posted: 2023-05-16
• Last updated: 2024-09-05

Locations

1 site across 1 country: China