Pharmacokinetics of PN-232 in Healthy Volunteers

Healthy Subjects Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819620
• Other study ID #: PN-232-01
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2021
• Est. completion date: June 16, 2022

Study information

• Verified date: September 2022
• Source: Protagonist Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 16, 2022
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• PN-232
Active Drug
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Australia	Protagonist Clinical Site	Adelaide	South Australia
Australia	Protagonist Study Site	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Protagonist Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of PN-232	Number and Severity of Adverse Events	10 days
Secondary	Peak concentration of PN-232 in plasma	Peak concentration (Cmax) of PN-232	10 days
Secondary	Area under the Concentration (AUC) of PN-232	AUC over 24 hours on Day 10 for PN-232	10 days