A Study of GensSci098 in Subjects With Graves' Disease
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Study ID
- NCT07286656
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- GenSci098
- Graves Disease
- Safety
- Tolerability
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GenSci098 — DRUG* Administration: Only one dose of GenSci098 will be given. * Route of Administration: Subcutaneous (injected under the skin). * Dose Levels: • Dose 1 • Dose 2• Dose 3• Dose 4
Study Details
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
Key Dates
- Start date
- Nov 21, 2025
- Status verified
- Feb 2026
- Primary completion
- Oct 28, 2026
- Completion
- Mar 18, 2027
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: GenSci098
Primary Outcome Measure
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]). [ Time Frame: 141 days ]
Central Contacts
- Zhongyan Shan, PHD+86 24 8328 2152
Related Studies
- Personalized Treatment in Thyroid DisordersRecruiting · Johns Hopkins University · Baltimore, Maryland
- Phase1/2a Study for IPG7236 in Patients With Advanced Solid TumorsPHASE1/PHASE2 · Recruiting · Nanjing Immunophage Biotech Co., Ltd · Portland, Oregon
- PyloPlus Urea Breath Test System Pediatric Safety and Efficacy StudyPHASE3 · Recruiting · ARJ Medical, Inc. · Doral, Florida
- Preoperative Corticosteroids in Autoimmune Thyroid DiseasePHASE4 · Recruiting · Indiana University · Indianapolis, Indiana