NCT06100627

A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers

A Randomized, Open-Label, Parallel Group, Phase 1 Study to Assess the Pharmacodynamic Effect of AP301 on Urinary Phosphorus Excretion in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Alebund Pty Ltd · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.

Detailed description

A total of 32 participants will participate in this study and the study consists of 3 periods such as screening period, hospitalization period and follow up period.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AP301	Orally administered

Timeline

• Start date: 2024-01-11
• Primary completion: 2024-02-08
• Completion: 2024-02-28
• First posted: 2023-10-25
• Last updated: 2024-05-10

Locations

1 site across 1 country: Australia