NCT04819620

Pharmacokinetics of PN-232 in Healthy Volunteers

A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.

Detailed description

Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses. Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days. Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion. In total, approximately 84 subjects will participate.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	PN-232	Active Drug
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2021-05-13
• Primary completion: 2021-12-17
• Completion: 2022-06-16
• First posted: 2021-03-29
• Last updated: 2022-10-03

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study