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Primary IgA NephropathyEarly Phase 1NCT07498673

A Study of YKST02 in Participants With Primary IgA Nephropathy

A Early Phase 1 study testing YKST02 in people with Primary IgA Nephropathy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary IgA Nephropathy
What is being tested?
YKST02
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
6 May 2026to 30 Jun 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiubai Li, MD, PhD contact

+86-27-85726338

qiubaili@hust.edu.cn

China1 site, 1 recruiting

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

    Wuhan, Hubei, 430022

    Qiubai Li, MD, PhD, +86-027-85726338, qiubaili@hust.edu.cn

    Qiubai Li, MD, PhD

    Recruiting

Other trials in China

About this study

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

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:

Read more
  • 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
Read the detailed description

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 period, and a follow-up period. During the treatment period, YKST02 will be administered by intravenous infusion. Dose levels and dosing schedules may be adjusted based on safety, tolerability, and emerging data to support dose escalation and determination of an appropriate dose level.

Safety assessments will include monitoring of adverse events, clinical laboratory evaluations, vital signs, and other relevant clinical parameters. Pharmacokinetic evaluations will characterize the concentration-time profile of YKST02. Pharmacodynamic and biomarker assessments will evaluate the biological activity of YKST02 and its effects on immune-related pathways.

Immunogenicity will be assessed by evaluating anti-drug antibodies. Preliminary efficacy will be explored using clinical measures relevant to IgAN.

Additional exploratory analyses may be performed to further characterize immune-related biomarkers and potential effects on renal pathology, as applicable.

Being tested
YKST02
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YKST02Drug

    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.

Study groups in NCT07498673
Study groupRoleWhat they receive
YKST02ExperimentalParticipants 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 assessments.
Receives: Drug: YKST02

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From first dose through Week 25

  2. Change from Baseline in UPCR

    Efficacy will be evaluated by the change from baseline in urine protein-to-creatinine ratio (UPCR).

    Measured: From baseline through Week 25

  3. Change from Baseline in eGFR

    Efficacy will be evaluated by the change from baseline in estimated glomerular filtration rate (eGFR).

    Measured: From baseline through Week 25

  4. Change from Baseline in Urinary Red Blood Cells

    Efficacy will be evaluated by the change from baseline in urinary red blood cells.

    Measured: From baseline through Week 25

Secondary outcomes (10)

  1. 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.

    Measured: From first dose through Week 25

  2. Maximum Observed Concentration (Cmax) of YKST02

    Maximum observed plasma concentration (Cmax) of YKST02 will be evaluated.

    Measured: From first dose through Week 25

  3. Half-life (t1/2) of YKST02

    Terminal elimination half-life (t1/2) of YKST02 will be evaluated.

    Measured: From first dose through Week 25

  4. Change from Baseline in Gd-IgA1

    Pharmacodynamic effects will be evaluated by the change from baseline in galactose-deficient IgA1 (Gd-IgA1).

    Measured: From baseline through Week 24.

  5. Change from Baseline in Serum Immunoglobulin Levels

    Changes from baseline in serum immunoglobulin levels will be assessed, including IgA, IgG, and IgM.

    Measured: From baseline through Week 24

  6. Change from Baseline in Complement Levels

    Changes from baseline in complement levels will be assessed, including complement components C3 and C4.

    Measured: From baseline through Week 24

  7. 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.

    Measured: From baseline through Week 25

  8. Changes in Lymphocyte Subsets

    Changes from baseline in peripheral blood lymphocyte subsets will be assessed, including B cell subsets and T cell subsets.

    Measured: From baseline through Week 24

  9. Changes in Lymphocyte Activation Markers

    Changes from baseline in activation status of lymphocyte populations will be assessed using relevant activation markers, as applicable.

    Measured: From baseline through Week 24

  10. Changes in Cytokine Levels

    Changes from baseline in cytokine levels relevant to immune and inflammatory responses will be assessed.

    Measured: From baseline through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start6 May 2026
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498673
Sponsor's protocol ID
YKST02-N01
Status last verified
May 2026
First submitted
23 Mar 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing YKST02 in people with Primary IgA Nephropathy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiubai Li, MD, PhD (+86-27-85726338, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose through Week 25). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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