Multiple subcutaneous injections of GenSci120 in healthy adults 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

This trial will test multiple subcutaneous doses of GenSci120 versus placebo in healthy adults to see if the drug is safe, well tolerated, and how it behaves in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07040930 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial will administer repeated subcutaneous injections of GenSci120 or placebo to healthy adult participants to characterize safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD). Participants will be enrolled into dose-escalation cohorts and monitored for adverse events, injection-site reactions, laboratory and ECG changes, and serial PK/PD sampling during dosing and follow-up. Key eligibility includes ages 18–55, BMI 18–30, minimum weight thresholds, and absence of clinically significant medical conditions, with contraception requirements for men and women of childbearing potential. The study is conducted at a single site in Shanghai to support dose selection for subsequent patient trials.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–55 with BMI 18–30 who meet the study weight and reproductive criteria and have no clinically significant medical history or abnormal screening results.

Not a fit: People with active rheumatoid arthritis, significant comorbidities, recent malignancy, severe allergies, immunodeficiency, or those unable to attend the Shanghai site are unlikely to benefit from participation.

Why it matters

Potential benefit: If GenSci120 shows an acceptable safety and PK/PD profile, it could enable further clinical testing that may eventually lead to a new treatment option for people with rheumatoid arthritis.

How similar studies have performed: Early-phase trials of other biologic or targeted agents for rheumatoid arthritis have led to successful later-stage therapies, but GenSci120 appears to be a novel compound with limited public clinical data to date.

Eligibility criteria

Inclusion Criteria:

1. Ages 18-55; ≥3 per gender for each cohort.
2. BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
3. No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
4. 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).
5. Able to provide informed consent; willing to comply with all study requirements

Exclusion Criteria:

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

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Principal investigator: Jing Zhang, M.D. — Huashan Hospital
• Study coordinator: Yiting Chi, Master

Conditions Rheumatoid Arthritis; phase Ib; healthy adult; multiple subcutaneous injections; GenSci120