NCT06732973

A Bioequivalence Study of JS005 Pre-filled Syringe and JS005 Auto-injector

A Randomized, Open- Label, Parallel Controlled Study to Compare the Pharmacokinetics of JS005 With a Pre-filled Syringe and a Pre-filled Automatic Syringe Subcutaneously Injected in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. After signing the informed consent form and completing the screening examination, if the subjects meet all the inclusion criteria and do not meet any exclusion criteria, they will be randomly assigned to treatment group A or treatment group B: treatment group A receives a single subcutaneous injection of JS005 300 mg through PFS, and treatment group B receives a single subcutaneous injection of JS005 300 mg through AI. Subjects were followed up until the 85th day of the study to evaluate the pharmacokinetic equivalence of JS005. 136 subjects are planned to be included in each group. The entire study cycle includes a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects will be admitted to the Phase I clinical research ward on the day before administration (D-1), and can only leave after completing all examinations and evaluations on the 11th day after administration. They will return to the clinical research center for follow-up on days 15, 22, 29, 43, 57, 71, and 85.

Conditions

• Health Volunteer

Interventions

Type	Name	Description
DRUG	JS005	JS005：The drug was administered by a single subcutaneous injection

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-06-06
• Completion: 2025-10-21
• First posted: 2024-12-13
• Last updated: 2025-12-16

Locations

1 site across 1 country: China