NCT07040930

Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GenSci120	a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
DRUG	Placebo	a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-07-05
• Completion: 2026-09-20
• First posted: 2025-06-27
• Last updated: 2025-08-06

Locations

1 site across 1 country: China