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

Healthy Subjects Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05503693
Study type Interventional
Source Alebund Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date December 6, 2022
Completion date July 21, 2023
View Details
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