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
Diagnosis of primary IgA nephropathy (IgAN)
Proteinuria above a protocol-defined threshold at screening
Receiving stable standard-of-care therapy for IgAN for an adequate duration prior to enrollment, unless contraindicated or not tolerated
Women of childbearing potential must have a negative pregnancy test prior to study drug administration and agree to use effective contraception; male participants must agree to use effective contraception
Secondary IgA nephropathy (e.g., associated with liver disease, autoimmune disorders, infections, or other systemic conditions)
Other clinically significant renal diseases unrelated to IgAN (e.g., diabetic nephropathy, lupus nephritis, vasculitis)
Nephrotic syndrome considered unsuitable for study participation
Rapidly progressive glomerulonephritis or rapidly declining renal function
Sequential
YKST02
DrugYKST02 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.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Change from Baseline in UPCR
Efficacy will be evaluated by the change from baseline in urine protein-to-creatinine ratio (UPCR).
Change from Baseline in eGFR
Efficacy will be evaluated by the change from baseline in estimated glomerular filtration rate (eGFR).
Change from Baseline in Urinary Red Blood Cells
Efficacy will be evaluated by the change from baseline in urinary red blood cells.
Area Under the Concentration-Time Curve (AUC) of YKST02
Area under the concentration-time curve (AUC), including AUC0-t and AUC0-∞, of YKST02 will be evaluated.
Maximum Observed Concentration (Cmax) of YKST02
Maximum observed plasma concentration (Cmax) of YKST02 will be evaluated.
Half-life (t1/2) of YKST02
Terminal elimination half-life (t1/2) of YKST02 will be evaluated.
Change from Baseline in Gd-IgA1
Pharmacodynamic effects will be evaluated by the change from baseline in galactose-deficient IgA1 (Gd-IgA1).
Changes in Renal Histopathology
Pre-specified analyses will include evaluation of renal biopsy samples using histopathological methods.
Changes in Immune-Related Biomarkers
Pre-specified analyses will include assessment of immune-related biomarkers, such as gene expression profiles and immune repertoire characteristics.
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