A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy
NCT05668403 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2026-04-30
Summary
This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy
Conditions
Interventions
- DRUG
-
B007
Drug: B007 injection Drug: Placebo injection
- DRUG
-
B007
Drug: B007 injection Drug: Placebo injection
- DRUG
-
B007
Drug: B007 injection Drug: Placebo injection
Sponsors & Collaborators
-
Shanghai Pharmaceuticals Holding Co., Ltd
collaborator INDUSTRY -
Shanghai Jiaolian Drug Research and Development Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-02
- Primary Completion
- 2026-12-30
- Completion
- 2027-12-30
Countries
- China
Study Locations
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