A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Rheumatoid Arthritis
NCT06857227 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2025-04-15
Summary
This study is a randomized controlled phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with rheumatoid arthritis.
Conditions
Interventions
- DRUG
-
GNC-038
Administration by intravenous infusion. Once a week (IV, QW), twice in total.
- DRUG
-
The control group will be set up in phase Ib, and an appropriate dose will be selected based on phase Ia data.
Sponsors & Collaborators
-
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Sichuan Baili Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-17
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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