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NOT YET RECRUITING
NCT07730632
PHASE2

Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase II Clinical Study Evaluating the Efficacy and Safety of QLS7305 in Patients With Primary IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Primary Membranous Nephropathy (PMN)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08-10

Completion Date

2028-08-11

Last Updated

2026-07-28

Healthy Volunteers

No

Interventions

DRUG

QLS7305 Injection

Route of administration: subcutaneous injection

Locations (1)

Peking University First Hospital

Beijing, China