NCT04621630

Pharmacokinetics of PN-235 in Healthy Volunteers

A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (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-235 in healthy volunteers. The study 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 a randomized, crossover solid dose comparison and effect of food study.

Detailed description

Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses. Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days. Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion. In total, approximately 102 subjects will participate.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PN-235	Active Drug
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2020-11-12
• Primary completion: 2021-09-19
• Completion: 2021-10-13
• First posted: 2020-11-09
• Last updated: 2022-02-18

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study