Healthy Subjects
Conditions
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.
Interventions
DRUGPN-232
Active Drug
DRUGPlacebo
Matching Placebo
Sponsors
Protagonist Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of PN-232 | 10 days | Number and Severity of Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak concentration of PN-232 in plasma | 10 days | Peak concentration (Cmax) of PN-232 |
| Area under the Concentration (AUC) of PN-232 | 10 days | AUC over 24 hours on Day 10 for PN-232 |
Countries
Australia
Outcome results
None listed