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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• Ages 18-55; ≥3 per gender for each cohort.

• BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).

• No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.

• Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH \>40 IU/L).

• Able to provide informed consent; willing to comply with all study requirements

Locations
Other Locations
China
Huashan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Yiting Chi, Master
chiyiting@genscigroup.com
+86 13482779422
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-09-20
Participants
Target number of participants: 30
Treatments
Experimental: GenSci120
Multiple ascending doses of GenSci120 administered subcutaneously (SC).
Experimental: Placebo
Multiple ascending doses of placebo administered subcutaneously (SC).
Related Therapeutic Areas
Arthritis
Rheumatoid Arthritis (RA)
Sponsors
Leads: Changchun GeneScience Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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