Rheumatoid Arthritis
Conditions
Keywords
phase Ib, healthy adult, multiple subcutaneous injections, GenSci120
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.
Interventions
DRUGGenSci120
a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
DRUGPlacebo
a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 169 days | maximum concentration |
| t1/2 | half-life | 169 days |
| CL/F | apparent clearance | 169 days |
| V/F | 169 days | apparent volume of distribution |
| plasma | 169 days | Concentration of GenSci120 in plasma samples. |
| cell counts of T cell subset | 169 days | cell counts 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 |
| Time of ADA | 169 days | Time of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration |
| RO of T cell subset | 169 days | Receptor occupancy (RO) of T cell subset detected by flow cytometry |
| AUC0-t, AUC0-∞ | 169 days | Area under drug concentration-time curve |
| Tmax | 169 days | time to maximum concentration |
Countries
China
Contacts
Primary ContactYiting Chi, Master
Outcome results
None listed