A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
NCT07749430 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2026-08-06
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ACG102 administered via intravenous injection in patients with refractory active systemic lupus erythematosus (SLE)
Conditions
- Refractory Active Systemic Lupus Erythematosus
Interventions
- DRUG
-
ACG102 Injection
All enrolled participants will receive multiple intravenous infusions of ACG102 at the dose level assigned to their cohort. Dose levels and dosing schedules may be adjusted based on emerging safety, tolerability, and PK/PD data.
Sponsors & Collaborators
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-15
- Primary Completion
- 2027-01-30
- Completion
- 2028-01-30
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