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

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called GenSci120 to see if it is safe and well-tolerated when given as multiple under-the-skin injections to healthy adults. The goal is to understand how the body processes the medicine and how the medicine affects the body. This early-phase study will help researchers learn important information before testing the medicine in people with rheumatoid arthritis, a condition that causes joint pain and swelling.

People who may be able to join the study are adults between 18 and 55 years old who are generally healthy, with a body weight and body mass index (BMI) within certain ranges. Both men and women can participate, but women must not be pregnant or breastfeeding and must use birth control if they can have children. Participants will receive several injections of either GenSci120 or a placebo (a harmless, inactive shot) without knowing which one they get. The study team will closely monitor their health through exams and tests to make sure the medicine is safe. If you are interested, you should be free from serious health problems, not taking other medications recently, and willing to follow all study rules. This study is not yet recruiting volunteers but will be done carefully to help develop new treatments for rheumatoid arthritis in the future.

Gender

ALL

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.