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Pharmacokinetics of PN-232 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04819620
Recruitment Status : Active, not recruiting
First Posted : March 29, 2021
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Protagonist Therapeutics, Inc.

Study Description
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Brief Summary:
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that 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 crossover solid dose comparison and effect of food study.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: PN-232 Drug: Placebo Phase 1

Detailed Description:

Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.

Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.

Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.

In total, approximately 84 subjects will participate.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Dose
Single dose administration
 Drug: PN-232
Active Drug

Drug: Placebo
Matching Placebo
Experimental: Multiple Dose
Multiple dose administration
 Drug: PN-232
Active Drug

Drug: Placebo
Matching Placebo
Experimental: Solid Dose Comparison
Solid dose administration
 Drug: PN-232
Active Drug


Outcome Measures
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Primary Outcome Measures :
  1. Safety of PN-232 [ Time Frame: 10 days ]
    Number and Severity of Adverse Events


Secondary Outcome Measures :
  1. Peak concentration of PN-232 in plasma [ Time Frame: 10 days ]
    Peak concentration (Cmax) of PN-232

  2. Area under the Concentration (AUC) of PN-232 [ Time Frame: 10 days ]
    AUC over 24 hours on Day 10 for PN-232


Eligibility Criteria
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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 kg/m2
  • 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
  • Subjects must be willing to attend required clinic visits
  • Subjects must be suitable candidates for study procedures

Key Exclusion Criteria:

  • Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
  • Subjects with a history of surgical resection of the stomach, small or large intestine
  • Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening
  • Subjects with clinically significant laboratory abnormalities
  • Subjects with corrected QT greater than 450 msec in males and 470 msec in females
  • Subjects who test positive for Hepatitis C or B, or HIV at Screening
  • Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
  • Subjects who test positive for drugs of abuse or alcohol at Screening
Contacts and Locations
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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): NCT04819620


Locations
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Australia, South Australia
Protagonist Clinical Site
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Protagonist Study Site
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Protagonist Therapeutics, Inc.
More Information
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Responsible Party: Protagonist Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04819620    
Other Study ID Numbers: PN-232-01
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022

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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