Clinical trial NCT04819620: Pharmacokinetics of PN-232 in Healthy Volunteers
Official title: A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Protagonist Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of PN-232
timeFrame: 10 days
Secondary outcomes:
measure: Peak concentration of PN-232 in plasma
timeFrame: 10 days
measure: Area under the Concentration (AUC) of PN-232
timeFrame: 10 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Protagonist Clinical Site
state: South Australia
city: Nedlands
country: Australia
facility: Protagonist Study Site
state: Western Australia
Study officials:
References: