A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- PN-232
- Conditions
- Healthy Subjects
- Sponsor
- Protagonist Therapeutics, Inc.
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Safety of PN-232
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Single Dose
Single dose administration
Intervention: PN-232
Single Dose
Single dose administration
Intervention: Placebo
Multiple Dose
Multiple dose administration
Intervention: PN-232
Multiple Dose
Multiple dose administration
Intervention: Placebo
Solid Dose Comparison
Solid dose administration
Intervention: PN-232
Outcomes
Primary Outcomes
Safety of PN-232
Time Frame: 10 days
Number and Severity of Adverse Events
Secondary Outcomes
- Peak concentration of PN-232 in plasma(10 days)
- Area under the Concentration (AUC) of PN-232(10 days)