NCT06308523

A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants

A Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Healthy Chinese Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Alebund Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants.

Detailed description

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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AP303 150 μg	AP303 Tablet 150 μg QD
DRUG	Placebo 150 μg	Placebo Tablet 150 μg QD
DRUG	AP303 300 μg	AP303 Tablet 300 μg QD
DRUG	Placebo 300 μg	Placebo Tablet 300 μg QD

Timeline

• Start date: 2024-03-18
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2024-03-13
• Last updated: 2024-10-22

Locations

1 site across 1 country: China