Pharmacokinetics of PN-232 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: PN-232
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose<br>Single dose administration | Drug: PN-232<br>* Active Drug<br>Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Multiple Dose<br>Multiple dose administration | Drug: PN-232<br>* Active Drug<br>Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Solid Dose Comparison<br>Solid dose administration | Drug: PN-232<br>* Active Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of PN-232 | Number and Severity of Adverse Events | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak concentration of PN-232 in plasma | Peak concentration (Cmax) of PN-232 | 10 days | 
| Area under the Concentration (AUC) of PN-232 | AUC over 24 hours on Day 10 for PN-232 | 10 days |