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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: PN-232

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Protagonist Clinical Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Protagonist Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Subjects must have BMI between 18 and 32 kg/m2
• Subjects must be non-smokers or social smokers
• Subjects must comply with contraception requirements
• Subjects must be willing to consume meals provided by the clinical center
• Subjects must be willing to attend required clinic visits
• Subjects must be suitable candidates for study procedures

Key Exclusion Criteria:

• Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
• Subjects with a history of surgical resection of the stomach, small or large intestine
• Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening
• Subjects with clinically significant laboratory abnormalities
• Subjects with corrected QT greater than 450 msec in males and 470 msec in females
• Subjects who test positive for Hepatitis C or B, or HIV at Screening
• Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
• Subjects who test positive for drugs of abuse or alcohol at Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose; Single dose administration	Drug: Placebo; Matching Placebo; Drug: PN-232; Active Drug
Experimental: Multiple Dose; Multiple dose administration	Drug: Placebo; Matching Placebo; Drug: PN-232; Active Drug
Experimental: Solid Dose Comparison; Solid dose administration	Drug: PN-232; Active Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of PN-232	Number and Severity of Adverse Events	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration of PN-232 in plasma	Peak concentration (Cmax) of PN-232	10 days
Area under the Concentration (AUC) of PN-232	AUC over 24 hours on Day 10 for PN-232	10 days

Collaborators and Investigators

• Sponsor: Protagonist Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PN-232-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes