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Pharmacokinetics of PN-235 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04621630
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : March 30, 2021
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04621630


Contacts
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Contact: Study Director 1-888-899-1543 ptgxclinicaltrials@ptgx-inc.com

Locations
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Australia
Nucleus Network Melbourne Clinic Recruiting
Melbourne, Australia
Sponsors and Collaborators
Protagonist Therapeutics, Inc.
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Responsible Party: Protagonist Therapeutics, Inc.
ClinicalTrials.gov 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