RecruitingPhase 1

A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients

China18 participantsStarted 2025-02-27

Plain-language summary

The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.

Who can participate

Age range30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female participants, ≥30 years of age at the time of signing the informed consent form.
✓. BMI (body mass index) 18-30 kg/m².
✓. Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..
✓. Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.
✓. Hemoglobin A1c ≥6.5% but ≤10.5% at the screening visit.
✓. Estimated GFR ≥30 mL/min/1.73m² but \< 60 mL/min/1.73m² at the screening visit.
✓. Urinary albumin to creatinine ratio ≥ 30 mg/g at the screening visit.

Exclusion criteria

✕. Chronic kidney disease other than type 2 diabetic kidney disease.
✕. Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.
✕. Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.
✕. Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.
✕. Peripheral edema above the ankle level at the screening or randomization visit.
✕. Confirmed (based on the average of 2 separate resting blood pressure measurements in a sitting position, after at least 5 minutes rest) systolic BP greater than 160 or less than 90 mmHg, and diastolic BP greater than 100 or less than 50 mmHg at screening.
✕. Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack, cardiovascular surgery within 6 months prior to the screening visit.
✕. Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG: e.g.

What they're measuring

Cmax

Timeframe: Day 1, Day 14

Tmax

Timeframe: Day 1, Day 14

AUC0-24h

Timeframe: Day 1

AUC0-last

Timeframe: Day 1

AUC0-inf

Timeframe: Day 1

AUC0-t

Timeframe: Day 14

t1/2

Timeframe: Day 1, Day 14

CL/F

Timeframe: Day 1

V/F

Timeframe: Day 1, Day 14

Trial details

NCT IDNCT06666283

SponsorAlebund Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-25

Contact for this trial

Yuran Zhang

+8613661548603 yuran.zhang@alebund.com

View on ClinicalTrials.gov More Diabetic Kidney Disease trials

Who can participate

Age range30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female participants, ≥30 years of age at the time of signing the informed consent form.
✓. BMI (body mass index) 18-30 kg/m².
✓. Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..
✓. Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.
✓. Hemoglobin A1c ≥6.5% but ≤10.5% at the screening visit.
✓. Estimated GFR ≥30 mL/min/1.73m² but \< 60 mL/min/1.73m² at the screening visit.
✓. Urinary albumin to creatinine ratio ≥ 30 mg/g at the screening visit.

Exclusion criteria

✕. Chronic kidney disease other than type 2 diabetic kidney disease.
✕. Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.
✕. Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.
✕. Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.
✕. Peripheral edema above the ankle level at the screening or randomization visit.
✕. Confirmed (based on the average of 2 separate resting blood pressure measurements in a sitting position, after at least 5 minutes rest) systolic BP greater than 160 or less than 90 mmHg, and diastolic BP greater than 100 or less than 50 mmHg at screening.
✕. Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack, cardiovascular surgery within 6 months prior to the screening visit.
✕. Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG: e.g.