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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 11, 2025 (before its estimated September 25, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary and study completion dates: Jan 25, 2025 to Sep 25, 2025
    • Start date changed from estimate of Nov 5, 2024 to Feb 27, 2025
    • Study sites: 0 to 1
    • Interventions: AP303 150μg (Drug), AP303 300μg (Drug), Placebo 150μg (Drug), Placebo 300μg (Drug) to AP303 150μg (Drug), Placebo 150μg (Drug)
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06666283
Lead Sponsor Alebund Pharmaceuticals
Conditions
(from sponsor)		 Diabetic Kidney Disease
Related terms Diabetic Nephropathies
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov