NCT05503693

A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects

A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Alebund Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.

Detailed description

The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AP303 50 μg	AP303 tablet
DRUG	AP303 150 μg	AP303 tablet
DRUG	AP303 300 μg	AP303 tablet
DRUG	AP303 600 μg	AP303 tablet
DRUG	Placebo 50 μg	Placebo tablet
DRUG	Placebo 150 μg	Placebo tablet
DRUG	Placebo 300 μg	Placebo tablet
DRUG	Placebo 600 μg	Placebo tablet

Timeline

• Start date: 2022-12-06
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2022-08-17
• Last updated: 2024-05-30

Locations

1 site across 1 country: Australia