Actively Recruiting
Randomized, Double-blind, Placebo-controlled Study of AP303 Safety and Pharmacology in Diabetic Kidney Disease Patients With Renal Impairment
Led by Alebund Pharmaceuticals · Updated on 2025-09-11
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a drug called AP303 in patients with Diabetic Kidney Disease (DKD) who have renal impairment. This is a phase 1, single-center, double-blind, randomized, placebo-controlled study designed to gather detailed information about how AP303 behaves in the body and its potential effects in this patient group. The study is sponsored by Alebund Pharmaceuticals and focuses on patients aged 30 years and older with specific kidney function and diabetes characteristics. Participants will be assigned to one of two dose groups, each including nine patients randomized in a 2:1 ratio to receive either AP303 or a placebo. The study drug, AP303, is administered orally once daily at a dose of 150 micrograms for a duration of two weeks. The placebo group receives a matching tablet. The trial closely monitors patients during and after the treatment period to evaluate safety and drug behavior. During the study, participants will undergo various assessments including blood tests for drug levels and kidney function, vital signs monitoring, electrocardiograms (ECG), physical examinations, and laboratory tests to detect any adverse events or abnormalities. These evaluations occur from day 1 through day 28 with specific timepoints for fasting glucose, lipid profiles, serum creatinine, and estimated glomerular filtration rate (eGFR). The study aims to collect comprehensive safety and pharmacological data over the course of about one month.
CONDITIONS
Brief 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 aged 30 years or older
- Body mass index (BMI) between 18 and 30 kg/m²
- Clinical diagnosis of Type 2 Diabetes Mellitus
- Stable dose of hypoglycemic drugs, including insulin, for at least two weeks before screening
- Stable dose of ACE inhibitors or Angiotensin II receptor blockers for at least four weeks prior to screening
- Hemoglobin A1c between 6.5% and 10.5% at screening
- Estimated glomerular filtration rate (eGFR) between 30 and less than 60 mL/min/1.73m² 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
- Use of corticosteroid immunotherapy or other immunosuppressants within three months before screening
- Recent acute kidney injury, renal surgery within six months, or prior renal transplantation
- Congestive heart failure classified as NYHA class II to IV within three months before screening
- Peripheral edema above the ankle at screening or randomization
- Blood pressure outside the range of systolic 90-160 mmHg and diastolic 50-100 mmHg at screening
- Recent major cardiovascular events or surgery within six months before screening
- Abnormal ECG parameters or significant arrhythmias
- Treatment with thiazolidinediones, PPARa agonists, or dual/multiple PPARa/g agonists within three months before screening
- Use of CYP2C8 inducers or inhibitors within one month before screening
- Chronic use of NSAIDs except low-dose aspirin within one month before screening
- Elevated liver enzymes or other significant liver abnormalities at screening
- Elevated creatine phosphokinase or history of drug-induced myopathy
- History of malignancy within five years, except certain cured skin and cervical cancers
- Recent significant acute infection within two weeks prior to study drug administration
- Positive tests for Hepatitis B, Hepatitis C, HIV, or syphilis at screening
- Recent use of investigational drugs within three months before study
- History of drug or alcohol abuse or excessive recent alcohol consumption
- Use of more than five cigarettes or nicotine products daily within two weeks prior to admission
- Medical or social conditions interfering with study participation or assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive either AP303 or placebo tablets daily to evaluate safety, tolerability, and pharmacology in diabetic kidney disease with renal impairment.
Multiple visits during dosing period
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100009
Actively Recruiting
Research Team
Y
Yuran Zhang
J
Jue Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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