RecruitingEarly Phase 1NCT07498673

A Study of YKST02 in Participants With Primary IgA Nephropathy

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YKST02 in Participants With Primary IgA Nephropathy


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

12 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of YKST02 and to explore its potential to treat adults with primary IgA nephropathy (IgAN). The study will also assess how the drug moves through the body and how it affects the immune system. The main questions it aims to answer are: * Is YKST02 safe and well tolerated? * Does YKST02 reduce protein levels in the urine? * How does YKST02 behave in the body (pharmacokinetics, PK)? * How does YKST02 affect the immune system (pharmacodynamics, PD)? Participants are adults with IgAN who have persistent proteinuria despite standard treatment. Participants will: * Receive YKST02 by intravenous (IV) infusion * Be monitored after each dose for safety * Attend clinic visits for safety assessments and laboratory tests * Provide blood and urine samples during the study and follow-up period


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called YKST02 for people with primary iga nephropathy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYKST02

YKST02 is an investigational drug administered by intravenous infusion. It is provided as a sterile formulation for clinical use. Dosing may vary based on study design and ongoing evaluation of safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) data.


Locations(1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07498673


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