Multiple subcutaneous injections of GenSci120 in healthy adults in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: chiyiting@genscigroup.com
• Phone: +86 13482779422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.