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A Study of YKST02 in Participants With Primary IgA Nephropathy Frühe Phase 1 12

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Die klinische Studie NCT07498673 untersucht Behandlung im Zusammenhang mit Primäre IgA-Nephropathie. Diese interventionsstudie der Frühe Phase 1 hat den Status noch nicht rekrutierend. Der Start ist für 31. März 2026 geplant, bis 12 Teilnehmer aufgenommen werden. Durchgeführt von Union Hospital, Tongji Medical College, Huazhong University of Science and Technology wird der Abschluss für 30. Juni 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung

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 beh...
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Ausführliche Beschreibung
This is a single-center, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 in adults with primary IgA nephropathy (IgAN).

Eligible participants are adults with IgAN and persistent proteinuria despite standard-of-care treatment.

The study consists of a screening period, a treatment...

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Offizieller Titel

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

Erkrankungen
Primäre IgA-Nephropathie
Weitere Studien-IDs
  • YKST02-N01
NCT-Nummer
NCT07498673
Studienbeginn (tatsächlich)
2026-03-31
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2027-06-30
Geplante Rekrutierung
12
Studientyp
Interventionsstudie
PHASE
Frühe Phase 1
Status
Noch nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Sequentiell
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellYKST02
Participants receive YKST02 administered by intravenous infusion in this single-arm, open-label, dose-escalation study. Participants receive an initial dosing phase followed by subsequent administrations at escalating dose levels. Dose levels and dosing schedules may be adjusted based on safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) data. A follow-up period is included for safety and efficacy asse...Mehr anzeigen
YKST02
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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).
From first dose through Week 25
Change from Baseline in UPCR
Efficacy will be evaluated by the change from baseline in urine protein-to-creatinine ratio (UPCR).
From baseline through Week 25
Change from Baseline in eGFR
Efficacy will be evaluated by the change from baseline in estimated glomerular filtration rate (eGFR).
From baseline through Week 25
Change from Baseline in Urinary Red Blood Cells
Efficacy will be evaluated by the change from baseline in urinary red blood cells.
From baseline through Week 25
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
From first dose through Week 25
Maximum Observed Concentration (Cmax) of YKST02
Maximum observed plasma concentration (Cmax) of YKST02 will be evaluated.
From first dose through Week 25
Half-life (t1/2) of YKST02
Terminal elimination half-life (t1/2) of YKST02 will be evaluated.
From first dose through Week 25
Change from Baseline in Gd-IgA1
Pharmacodynamic effects will be evaluated by the change from baseline in galactose-deficient IgA1 (Gd-IgA1).
From baseline through Week 24.
Change from Baseline in Serum Immunoglobulin Levels
Changes from baseline in serum immunoglobulin levels will be assessed, including IgA, IgG, and IgM.
From baseline through Week 24
Change from Baseline in Complement Levels
Changes from baseline in complement levels will be assessed, including complement components C3 and C4.
From baseline through Week 24
Immunogenicity of YKST02
Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs). Neutralizing antibodies (NAbs) will be evaluated in participants who are ADA-positive.
From baseline through Week 25
Changes in Lymphocyte Subsets
Changes from baseline in peripheral blood lymphocyte subsets will be assessed, including B cell subsets and T cell subsets.
From baseline through Week 24
Changes in Lymphocyte Activation Markers
Changes from baseline in activation status of lymphocyte populations will be assessed using relevant activation markers, as applicable.
From baseline through Week 24
Changes in Cytokine Levels
Changes from baseline in cytokine levels relevant to immune and inflammatory responses will be assessed.
From baseline through Week 24
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 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
  • Able to understand the study procedures and provide written informed consent

  • 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
  • Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m²
  • Immunodeficiency or low immunoglobulin G (IgG) levels below normal
  • Clinically significant abnormal laboratory findings (e.g., hematologic, hepatic, or coagulation abnormalities)
  • Requirement for systemic corticosteroids for concomitant conditions
  • Use of immunosuppressive, targeted, or biologic therapies within a defined period prior to screening or anticipated use during the study
  • Prior treatment with B-cell-depleting or other targeted biologic therapies within a defined period
  • History of demyelinating disorders (e.g., multiple sclerosis)
  • Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening
  • History of organ transplantation or planned transplantation during the study
  • Current dialysis or anticipated need for dialysis during the study
  • Major surgery within 4 weeks prior to screening or planned during the study
  • Active infection requiring systemic therapy, recent serious infection, or chronic/recurrent infections
  • Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
  • Active or untreated latent tuberculosis
  • History of splenectomy
  • Uncontrolled comorbidities (e.g., poorly controlled hypertension or diabetes)
  • Malignancy within the past 5 years, except adequately treated non-invasive cancers
  • Known hypersensitivity to YKST02 or its components
  • Receipt of another investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to screening
  • Receipt of live or attenuated vaccines within 4 weeks prior to screening or planned during the study
  • Any condition that, in the investigator's judgment, would make the participant unsuitable for the study
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology logoUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Verantwortliche Partei
Qiubai Li, Hauptprüfer, Professor and Chief Physician, Head of Rheumatology Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Zentrale Studienkontakte
Kontakt: Qiubai Li, MD, PhD, +86-27-85726338, [email protected]
1 Studienstandorte in 1 Ländern

Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China
Qiubai Li, MD, PhD, Kontakt, +86-027-85726338, [email protected]
Qiubai Li, MD, PhD, Hauptprüfer