Status:
COMPLETED
Pharmacokinetics of PN-232 in Healthy Volunteers
Lead Sponsor:
Protagonist Therapeutics, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04819620
Start Date
May 13 2021
End Date
June 16 2022
Last Update
October 3 2022
Active Locations (2)
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1
Protagonist Clinical Site
Adelaide, South Australia, Australia, 5000
2
Protagonist Study Site
Nedlands, Western Australia, Australia, 6009