Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
- Summary
- The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
- Short title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-07-29
- First posted
- 2025-09-03
- Registry last updated
- 2026-08-05
- Primary completion date
- 2026-07-29
- Start date
- 2025-10-07
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Protagonist Therapeutics, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07153146
- ClinicalTrials.gov ID
- NCT07153146
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- Double masking
- Masking description
- Part 1 \& Part 2 is masked; Part 3, Part 4 and Part 5 are open label
- Masked roles
- Participants, Investigators
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timeframe: Predose to 7 days after last dose
Evaluate the safety and tolerability of PN-881 in comparison to placebo after single and multiple doses in healthy subjects assessed for severity, seriousness, and relation to the investigational product.
Maximum observed plasma concentration (Cmax) of PN-881
Timeframe: 48 hours following the first dose and the last dose
Highest measured plasma concentration of PN-881 following oral administration.
Area under the plasma concentration-time curve (AUC) of PN-881
Timeframe: Predose to 48 hours after the first and last dose.
AUC calculated from 0 to infinity.
Levels of biomarker in serum
Timeframe: Day 1 Predose up to 48 hours post (last) dose
Pharmacodynamics (PD) of PN-881 by means of increase in levels of biomarker by PN-881 after single and multiple oral doses.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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)
- Nucleus NetworkMelbourne, Australia