A Phase 1 Randomized, Double-blind, Placebo-controlled Study of AP303 Safety and Effects in Adults with Diabetic Kidney Disease and Kidney Impairment Over 2 Weeks

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 21 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.

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