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

NCT07153146 | Recruiting Phase 1

• 1 other identifier: PN-881-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

PN-881

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  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.

  Predose to 7 days after last dose

Secondary Outcomes (3)

• Maximum observed plasma concentration (Cmax) of PN-881

  48 hours following the first dose and the last dose

• Area under the plasma concentration-time curve (AUC) of PN-881

  Predose to 48 hours after the first and last dose.

• Levels of biomarker in serum

  Day 1 Predose up to 48 hours post (last) dose

Study Arms (6)

PN-881 Oral Solution Single Ascending Dose

EXPERIMENTAL

PN-881 Oral Solution Single Ascending Dose

Drug: PN-881 Oral Solution

Placebo Oral Solution Single Ascending Dose

PLACEBO COMPARATOR

Placebo single ascending doses

Drug: Placebo

PN-881 Oral Solution Multiple Ascending Dose

EXPERIMENTAL

PN-881 Multiple Ascending Doses

Drug: PN-881 Oral Solution

Placebo Oral Solution Multiple Ascending Dose

PLACEBO COMPARATOR

Placebo, multiple ascending doses

Drug: Placebo

PN-881 Oral Tablet Single Dose

EXPERIMENTAL

PN-881 oral tablet single dose

Drug: PN-881 Oral Tablet

PN-881 Oral Tablet Multiple Dose

EXPERIMENTAL

PN-881 oral tablet multiple dose

Drug: PN-881 Oral Tablet

Interventions

PN-881 Oral Tablet DRUG

PN-881 oral tablet

PN-881 Oral Tablet Multiple Dose; PN-881 Oral Tablet Single Dose

Placebo DRUG

Placebo

Placebo Oral Solution Multiple Ascending Dose; Placebo Oral Solution Single Ascending Dose

PN-881 Oral Solution DRUG

PN-881 Oral Solution

PN-881 Oral Solution Multiple Ascending Dose; PN-881 Oral Solution Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Protagonist Therapeutics, Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

RECRUITING

Central Study Contacts

Clinical Study Director

CONTACT

+61 1800 243 733; melbourne@nucleusnetwork.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part 1 \& Part 2 is masked; Part 3, Part 4 and Part 5 are open label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 3, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)