NCT07153146

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.

A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.

Detailed description

PN-881 will be administered in oral solution and tablet formulations, with dosing under fasting or fed conditions depending on the study part. The study consists of five parts: Part 1 - Single Ascending Dose (SAD): Randomised, double-blind, placebo-controlled Part 2 - Multiple Ascending Dose (MAD): Randomised, double-blind, placebo-controlled Part 3 - Tablet Formulation Comparison: Open-label, crossover design; participants will receive different oral tablet formulations Part 4 - Effect of Food: Open-label, crossover design to assess the effect of food on the pharmacokinetics of PN-881. Participants will receive PN-881 tablet formulations in fasted and fed conditions. Part 5 - Dosing Frequency Comparison: Open-label, randomized study comparing once-daily and twice-daily dosing.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	PN-881 Oral Solution	PN-881 Oral Solution
DRUG	PN-881 Oral Tablet	PN-881 oral tablet
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-10-07
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2025-09-03
• Last updated: 2025-12-16

Locations

1 site across 1 country: Australia