Pharmacokinetics of PN-232 in Healthy Volunteers

NCT04819620 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PN-232-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Safety of PN-232

  Number and Severity of Adverse Events

  10 days

Secondary Outcomes (2)

• Peak concentration of PN-232 in plasma

  10 days

• Area under the Concentration (AUC) of PN-232

  10 days

Study Arms (3)

Single Dose

EXPERIMENTAL

Single dose administration

Drug: PN-232; Drug: Placebo

Multiple Dose

EXPERIMENTAL

Multiple dose administration

Drug: PN-232; Drug: Placebo

Solid Dose Comparison

EXPERIMENTAL

Solid dose administration

Drug: PN-232

Interventions

PN-232 DRUG

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Protagonist Therapeutics, Inc.: lead

Study Sites (2)

Protagonist Clinical Site

Adelaide, South Australia, 5000, Australia

Location

Protagonist Study Site

Nedlands, Western Australia, 6009, Australia

Location

Study Design

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

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: May 13, 2021
• Primary Completion: December 17, 2021
• Study Completion: June 16, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

AU (2)