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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT07040930

Run by

Changchun GeneScience Pharmaceutical Co., Ltd.

People needed

30

Starts

2025-08-01

Expected to finish

2026-09-20

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Allergy to GenSci120 or severe allergies.
• Injection site issues affecting evaluation.
• Significant medical conditions impacting study outcome.
• History of malignant tumors, including listed cancers.
• Seizure history, head injury causing unconsciousness.
• Psychiatric disorders impairing daily activities or cognitive issues.
• Severe immunodeficiency (e.g., HIV).
• Recent trauma, surgery, or GI issues affecting absorption.
• Recent severe infections or antimicrobial treatments.
• Live vaccines within a month prior to screening.
• Abnormal vital signs/ECG: BP extremes, QTcF >450ms.
• Positive for hepatitis B/C, HIV, syphilis during screening.
• Positive TB test via IGRA.
• Recent use of immunosuppressive or targeted therapies.
• Medication use within 14 days prior to randomization.
• Participation in other clinical trials recently/currently.
• Excessive alcohol consumption (over six months).
• Heavy smoking, unwillingness to quit, positive nicotine tests.
• Positive drug screen for specific substances.
• Recent soft/hard drug use within specified periods.
• Blood donation/product receipt recently or poor venous access.
• Study staff involved in the trial.
• Other conditions deemed unsuitable by investigators.

Where it is running

• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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