A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
NCT06666283 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-09-11
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.
Conditions
- Diabetic Kidney Disease
Interventions
- DRUG
-
AP303 150μg
AP303 Tablet 150μg QD
- DRUG
-
Placebo 150μg
Placebo Tablet 150μg QD
Sponsors & Collaborators
-
Alebund Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Hong Zhang · Peking University First Hospital
-
Ying Gao · Peking University First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-27
- Primary Completion
- 2025-09-25
- Completion
- 2025-09-25
Countries
- China
Study Locations
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