NCT06666283

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

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Alebund Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible patients will be enrolled into one of the two dose cohorts, each cohort will include 9 participants randomized to AP303 and placebo at a 2:1 ratio (6 on AP303 and 3 on placebo).

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	AP303 150μg	AP303 Tablet 150μg QD
DRUG	Placebo 150μg	Placebo Tablet 150μg QD

Timeline

• Start date: 2025-02-27
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2024-10-30
• Last updated: 2025-09-11

Locations

1 site across 1 country: China