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Pharmacokinetics of PN-235 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04621630
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : March 30, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PN-235 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Part 1 blinded, Part 2 blinded, Part 3 unblinded
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Single Dose
Single dose administration
Drug: PN-235
Active Drug
Other Name: Active Drug

Drug: Placebo
Matching Placebo

Experimental: Multiple Dose
Multiple dose administration
Drug: PN-235
Active Drug
Other Name: Active Drug

Drug: Placebo
Matching Placebo

Experimental: Solid Dose Comparison
Solid dose administartion
Drug: PN-235
Active Drug
Other Name: Active Drug

Primary Outcome Measures :
  1. Safety of PN-235 [ Time Frame: 10 days ]
    Number and severity of Adverse Events

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04621630

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Contact: Study Director 1-888-899-1543

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Nucleus Network Melbourne Clinic Recruiting
Melbourne, Australia
Sponsors and Collaborators
Protagonist Therapeutics, Inc.
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Responsible Party: Protagonist Therapeutics, Inc. Identifier: NCT04621630    
Other Study ID Numbers: PN-235-01
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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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