Pharmacokinetics of PN-232 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: PN-232; Drug: Placebo

• Registration Number: NCT04819620
• Lead Sponsor: Protagonist Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Study Start: 2021-05-13
• Primary Completion: 2021-12-17
• Study Completion: 2022-06-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple Dose	PN-232	Multiple dose administration
Single Dose	Placebo	Single dose administration
Multiple Dose	Placebo	Multiple dose administration
Solid Dose Comparison	PN-232	Solid dose administration
Single Dose	PN-232	Single dose administration

Primary Outcome Measures

Name	Time	Method
Safety of PN-232	10 days	Number and Severity of Adverse Events

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Protagonist Study Site; 🇦🇺 Nedlands, Western Australia, Australia

Protagonist Clinical Site; 🇦🇺 Adelaide, South Australia, Australia