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

Not Applicable

Not yet recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: GenSci120; Drug: Placebo

• Registration Number: NCT07040930
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-27
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03
• Study Start: 2025-07-31
• Primary Completion: 2026-07-05
• Study Completion: 2026-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GenSci120	GenSci120	Multiple ascending doses of GenSci120 administered subcutaneously (SC).
Placebo	Placebo	Multiple ascending doses of placebo administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
TEAEs	169 days	Incidence and severity of treatment-emergent adverse events
SAEs	169 days	Incidence and severity of serious adverse events
CSfadf	169 days	Clinically significant changes from baseline

Secondary Outcome Measures

Name	Time	Method
Tmax	169 days	time to maximum concentration
t1/2	half-life	169 days
Cmax	169 days	maximum concentration
CL/F	apparent clearance	169 days
V/F	169 days	apparent volume of distribution
RO of T cell subset	169 days	Receptor occupancy (RO) of T cell subset detected by flow cytometry
Incidence of ADA	169 days	Incidence of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration
AUC0-t, AUC0-∞	169 days	Area under drug concentration-time curve
cell counts of T cell subset	169 days	cell counts of T cell subset detected by flow cytometry
plasma	169 days	Concentration of GenSci120 in plasma samples.
Time of ADA	169 days	Time of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China