Pharmacokinetics of PN-235 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PN-235; Drug: Placebo

• Registration Number: NCT04621630
• Lead Sponsor: Protagonist Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Study Start: 2020-11-12
• Primary Completion: 2021-09-19
• Study Completion: 2021-10-13
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Subjects must have BMI between 18 and 32
• 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

Key

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple Dose	PN-235	Multiple dose administration
Multiple Dose	Placebo	Multiple dose administration
Single Dose	Placebo	Single dose administration
Solid Dose Comparison	PN-235	Solid dose administartion
Single Dose	PN-235	Single dose administration

Primary Outcome Measures

Name	Time	Method
Safety of PN-235	10 days	Number and severity of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of PN-235 in plasma	10 days	Peak concentration (Cmax) of PN-235
Area Under the Concentration (AUC) of PN-235	10 days	AUC over 24 hours on Day 10 for PN-235

Trial Locations

Locations (1)

Nucleus Network Melbourne Clinic; 🇦🇺 Melbourne, Australia