Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)
NCT07730632 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-07-28
Summary
QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. After subcutaneous (SC) administration, it can inhibit C3 synthesis through the RNA interference (RNAi) mechanism, reduce circulating C3 protein levels, decrease the generation of complement-activated C5 convertase, and inhibit complement pathway activation. It is expected to become an effective treatment for complement-mediated kidney diseases and hematological disorders.
Conditions
- IgAN - IgA Nephropathy
- Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
- C3 Glomerulopathy (C3G)
- Primary Membranous Nephropathy
Interventions
- DRUG
-
QLS7305 Injection
Route of administration: subcutaneous injection
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-10
- Primary Completion
- 2028-08-10
- Completion
- 2028-08-11
Countries
- China
Study Locations
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