Pharmacokinetics of PN-235 in Healthy Volunteers

Protagonist Therapeutics, Inc.107 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

107

Conditions

Healthy Volunteers

Interventions

PN-235DRUG

Active Drug

PlaceboDRUG

Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nucleus Network Melbourne Clinic

Melbourne, Australia

Outcomes

Primary Outcomes

Safety of PN-235

Number and severity of Adverse Events

Time frame: 10 days

Secondary Outcomes

Pharmacokinetics (PK) of PN-235 in plasma

Peak concentration (Cmax) of PN-235

Time frame: 10 days

Area Under the Concentration (AUC) of PN-235

AUC over 24 hours on Day 10 for PN-235

Time frame: 10 days

Data from ClinicalTrials.gov

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