Actively Recruiting
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
Led by Protagonist Therapeutics, Inc. · Updated on 2025-12-16
142
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
CONDITIONS
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants of non-childbearing potential, aged 18-65 years inclusive
- Body mass index (BMI) between 18 and 32 kg/m8 (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
You will not qualify if you...
- History or presence of significant cardiovascular, gastrointestinal, hepatic, renal, neurological, psychiatric, or allergic diseases
- History of cancer except adequately treated non-melanoma skin cancer
- Positive test for hepatitis B, hepatitis C, or HIV at screening
- History of substance abuse or intravenous recreational drug use within the past 2 years
- Significant infection or fever over 386C within 2 weeks prior to screening
- Use of prescription, non-prescription drugs, or herbal supplements within 7 days or 5 half-lives before dosing unless approved by the investigator
- Abnormal supine blood pressure or ECG outside study-defined ranges
- Use of tobacco or nicotine products exceeding 5 cigarettes/day or 2 chews/day
- Consumption of more than 21 alcohol units/week for males or more than 14 units/week for females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
C
Clinical Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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