RecruitingPhase 1NCT07153146

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.

A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects

Sponsor

Protagonist Therapeutics, Inc.

Enrollment

142 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.

Min Age: 18 YearsMax Age: 65 Years

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

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)