Pharmacokinetics of PN-235 in Healthy Volunteers

February 16, 2022 updated by: Protagonist Therapeutics, Inc.

A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Nucleus Network Melbourne Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Dose
Single dose administration
Drug: Placebo
Matching Placebo
Drug: PN-235
Active Drug
Other Names:
  • Active Drug
Experimental: Multiple Dose
Multiple dose administration
Drug: Placebo
Matching Placebo
Drug: PN-235
Active Drug
Other Names:
  • Active Drug
Experimental: Solid Dose Comparison
Solid dose administartion
Drug: PN-235
Active Drug
Other Names:
  • Active Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of PN-235
Time Frame: 10 days
Number and severity of Adverse Events
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of PN-235 in plasma
Time Frame: 10 days
Peak concentration (Cmax) of PN-235
10 days
Area Under the Concentration (AUC) of PN-235
Time Frame: 10 days
AUC over 24 hours on Day 10 for PN-235
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protagonist Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Actual)

September 19, 2021

Study Completion (Actual)

October 13, 2021

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PN-235-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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