Status:
RECRUITING
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
Lead Sponsor:
Protagonist Therapeutics, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
Detailed Description
PN-881 will be administered in oral solution and tablet formulations, with dosing under fasting or fed conditions depending on the study part. The study consists of five parts: Part 1 - Single Ascen...
Eligibility Criteria
Inclusion
- Healthy male and female participants of non-childbearing potential, aged 18-65 years inclusive
- Body mass index (BMI) between 18 and 32 kg/m² (inclusive) at screening
- Willing and able to comply with all study requirements and provide written informed consent
- Male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose
Exclusion
- Clinically significant history or presence of cardiovascular, gastrointestinal, hepatic, renal, neurological, psychiatric, or allergic diseases
- History of neoplastic disease (except adequately treated non-melanoma skin cancer)
- Positive test for hepatitis B, hepatitis C, or HIV at screening
- History of substance abuse or recreational IV drug use within the past 2 years
- Clinically significant infection or fever (\>38°C) within 2 weeks prior to screening
- Use of any prescription/non-prescription drugs or herbal supplements within 7 days or 5 half-lives before dosing (unless approved by investigator)
- Supine blood pressure or ECG abnormalities outside protocol-defined ranges
- Use of tobacco/nicotine products exceeding 5 cigarettes/day or 2 chews/day
- Consumption of \>21 alcohol units/week (males) or \>14 units/week (females)
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT07153146
Start Date
October 7 2025
End Date
June 15 2026
Last Update
December 16 2025
Active Locations (1)
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1
Nucleus Network
Melbourne, Victoria, Australia, 3004