Pharmacokinetics of PN-235 in Healthy Volunteers

NCT04621630 | Completed Phase 1 FDA Drug

• 1 other identifier: PN-235-01
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety of PN-235

  Number and severity of Adverse Events

  10 days

Secondary Outcomes (2)

• Pharmacokinetics (PK) of PN-235 in plasma

  10 days

• Area Under the Concentration (AUC) of PN-235

  10 days

Study Arms (3)

Single Dose

EXPERIMENTAL

Single dose administration

Drug: PN-235; Drug: Placebo

Multiple Dose

EXPERIMENTAL

Multiple dose administration

Drug: PN-235; Drug: Placebo

Solid Dose Comparison

EXPERIMENTAL

Solid dose administartion

Drug: PN-235

Interventions

PN-235 DRUG

Active Drug

Also known as: Active Drug

Multiple Dose; Single Dose; Solid Dose Comparison

Placebo DRUG

Matching Placebo

Multiple Dose; Single Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Protagonist Therapeutics, Inc.: lead

Study Sites (1)

Nucleus Network Melbourne Clinic

Melbourne, Australia

Location

Related Publications (1)

• Knight B, Tammara B, Modi NB, Dallas S, Mardirosian S, Wang J, Laenen A, Leclercq L, DiLoreto K, Adriaenssen L, Moss D, Polidori D, Chaudhuri SR, Park S, Sensenhauser C, Ndifor A, Sukumaran S, Baguet T, Shi Y, Patel S, Geist B, Fourie A, Patch R, Sun C, Barros SA, Somani S, Monshouwer M. Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling. Dermatol Ther (Heidelb). 2025 Sep;15(9):2495-2520. doi: 10.1007/s13555-025-01454-7. Epub 2025 Jul 8.

  PMID: 40629250 DERIVED

MeSH Terms

Interventions

Bulk Drugs

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 blinded, Part 2 blinded, Part 3 unblinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 9, 2020
• Study Start: November 12, 2020
• Primary Completion: September 19, 2021
• Study Completion: October 13, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

AU (1)