NCT07040930 Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.
| NCT ID | NCT07040930 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-08-01 with a primary completion date of 2026-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jing Zhang, M.D.
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT07040930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07040930 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07040930 currently recruiting?
Yes, NCT07040930 is actively recruiting participants. Contact the research team at chiyiting@genscigroup.com for enrollment information.
Where is the NCT07040930 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07040930 clinical trial?
NCT07040930 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. The principal investigator is Jing Zhang, M.D. at Huashan Hospital. The trial plans to enroll 30 participants.
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