Pharmacokinetics of PN-235 in Healthy Volunteers

A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04621630

Enrollment

107

Registered

2020-11-09

Start date

2020-11-12

Completion date

2021-10-13

Last updated

2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Detailed description

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.

Interventions

DRUGPN-235

Active Drug

DRUGPlacebo

Matching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Part 1 blinded, Part 2 blinded, Part 3 unblinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of PN-235	10 days	Number and severity of Adverse Events

Secondary

Measure	Time frame	Description
Pharmacokinetics (PK) of PN-235 in plasma	10 days	Peak concentration (Cmax) of PN-235
Area Under the Concentration (AUC) of PN-235	10 days	AUC over 24 hours on Day 10 for PN-235

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026