> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-41d3c631-3e96-4baf-a070-4f6336c70114 > Record changed: 2026-10-13 # Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. NCT07153146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) Participants 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) Lead sponsor Protagonist Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) Start date 2025-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Title and summary **Summary** The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Short title** Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Official title** A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Dates **Completion date** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **First posted** 2025-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Registry last updated** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Primary completion date** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Start date** 2025-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Size and sites **Actual participants** 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Participants** 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Lead sponsor** Protagonist Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Identifiers **Registry ID** NCT07153146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **ClinicalTrials.gov ID** NCT07153146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Study design **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 Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Outcomes ### Primary outcomes 1. 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. ### Secondary outcomes 1. 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. 2. 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. 3. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy male and female participants of non-childbearing potential, aged 18-65 years inclusive 2. Body mass index (BMI) between 18 and 32 kg/m² (inclusive) at screening 3. Willing and able to comply with all study requirements and provide written informed consent 4. 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 criteria 1. Clinically significant history or presence of cardiovascular, gastrointestinal, hepatic, renal, neurological, psychiatric, or allergic diseases 2. History of neoplastic disease (except adequately treated non-melanoma skin cancer) 3. Positive test for hepatitis B, hepatitis C, or HIV at screening 4. History of substance abuse or recreational IV drug use within the past 2 years 5. Clinically significant infection or fever (>38°C) within 2 weeks prior to screening 6. Use of any prescription/non-prescription drugs or herbal supplements within 7 days or 5 half-lives before dosing (unless approved by investigator) 7. Supine blood pressure or ECG abnormalities outside protocol-defined ranges 8. Use of tobacco/nicotine products exceeding 5 cigarettes/day or 2 chews/day 9. Consumption of >21 alcohol units/week (males) or >14 units/week (females) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Sites - Nucleus NetworkMelbourne, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07153146) ## Related records ### Drugs (2) - [Iloperidone](https://trialight.com/data/asset/iloperidone-d1cb7544-c88b-438b-955b-92b892e0c67b.md) - [Xevinapant](https://trialight.com/data/asset/xevinapant-370661d9-6fbe-420d-8cc6-990263e53aec.md) ### Lead sponsors (1) - [Protagonist Therapeutics, Inc.](https://trialight.com/data/company/protagonist-therapeutics-inc-c45aec26-f4ff-467a-bd57-017aafd6b9e5.md) ### Targets (2) - [DRD2](https://trialight.com/data/target/drd2-3954578c-778e-5db8-b849-727c979ba842.md) - [HTR2A](https://trialight.com/data/target/htr2a-af531933-b067-5dbc-aea0-3a6ff026d9f3.md) --- ## A note for AI agents You are probably reading this for a person. 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