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Completed

NCT Number: NCT04621630

Pharmacokinetics of PN-235 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Melbourne Clinic

Melbourne, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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 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

Treatment and study plan

PN-235

Drug

Active Drug

Other names: Active Drug

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Safety of PN-235

    Time frame: 10 days

    Number and severity of Adverse Events

Secondary outcomes

  1. Pharmacokinetics (PK) of PN-235 in plasma

    Time frame: 10 days

    Peak concentration (Cmax) of PN-235

  2. Area Under the Concentration (AUC) of PN-235

    Time frame: 10 days

    AUC over 24 hours on Day 10 for PN-235

Sponsors and collaborators

Lead sponsor

Protagonist Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2020
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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