Actively Recruiting
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
Led by Alebund Pharmaceuticals · Updated on 2025-09-11
18
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants, 6530 years of age at the time of signing the informed consent form.
- Body mass index (BMI) between 18 and 30 kg/m�b2.
- Clinical diagnosis of Type 2 Diabetes Mellitus and taking at least one type of hypoglycemic drug with stable doses for at least two weeks before screening.
- Stable dose of angiotensin converting enzyme inhibitor (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.
- Hemoglobin A1c between 6.5% and 10.5% at screening.
- Estimated glomerular filtration rate (GFR) between 30 and less than 60 mL/min/1.73m�b2 at screening.
- Urinary albumin to creatinine ratio of 30 mg/g or higher at screening.
You will not qualify if you...
- Chronic kidney disease other than type 2 diabetic kidney disease.
- Receiving corticosteroid immunotherapy or other immunosuppressants within 3 months before screening.
- Recent acute kidney injury, renal surgery within 6 months, or renal transplantation.
- Congestive heart failure classified as NYHA class II to IV within 3 months before screening.
- Peripheral edema above the ankle level at screening or randomization.
- Blood pressure outside the range: systolic >160 or <90 mmHg, diastolic >100 or <50 mmHg at screening.
- Recent myocardial infarction, acute coronary syndrome, stroke, transient ischemic attack, or cardiovascular surgery within 6 months before screening.
- Abnormal ECG parameters including QTc interval prolongation, bradycardia, tachycardia, or other significant abnormalities.
- Implanted cardiac pacemaker or significant arrhythmias (e.g., atrial fibrillation, atrial flutter, bundle branch block, Wolf-Parkinson-White Syndrome).
- Treatment with thiazolidinediones, PPARa agonists, or dual/multiple PPARa/g agonists within 3 months before screening.
- Treatment with CYP2C8 inducers or strong/moderate inhibitors within 1 month before screening.
- Chronic use of NSAIDs except stable low dose aspirin or acetaminophen in the last month before screening.
- Elevated liver enzymes (ALT or AST >1.5 times upper limit) or other clinically significant liver abnormalities at screening.
- Elevated creatine phosphokinase (CPK) >3 times upper limit or history of drug-induced myopathy.
- History of malignancy within 5 years before screening, except certain skin cancers and cervical carcinoma in situ.
- Significant acute infection or illness within 2 weeks before study drug administration.
- Positive tests for Hepatitis B, Hepatitis C, HIV, or syphilis at screening.
- Use of investigational drugs within 3 months or 5 half-lives before study start.
- History of drug or alcohol abuse; excessive alcohol consumption within 3 months before screening.
- Smoking more than 5 cigarettes or nicotine products per day within 2 weeks before admission.
- Medical or social conditions that might interfere with compliance with study visits or assessments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100009
Actively Recruiting
Research Team
Y
Yuran Zhang
CONTACT
J
Jue Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here