A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Diabetic Kidney Disease Patients With Renal Impairment.
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.
• 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.