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

NCT ID: NCT07153146

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-07

Study Completion Date

2026-06-15

Brief Summary

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

Detailed Description

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PN-881 will be administered in oral solution and tablet formulations, with dosing under fasting or fed conditions depending on the study part.

The study consists of five parts:

Part 1 - Single Ascending Dose (SAD): Randomised, double-blind, placebo-controlled Part 2 - Multiple Ascending Dose (MAD): Randomised, double-blind, placebo-controlled Part 3 - Tablet Formulation Comparison: Open-label, crossover design; participants will receive different oral tablet formulations Part 4 - Effect of Food: Open-label, crossover design to assess the effect of food on the pharmacokinetics of PN-881. Participants will receive PN-881 tablet formulations in fasted and fed conditions.

Part 5 - Dosing Frequency Comparison: Open-label, randomized study comparing once-daily and twice-daily dosing.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Part 1 \& Part 2 is masked; Part 3, Part 4 and Part 5 are open label

Study Groups

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PN-881 Oral Solution Single Ascending Dose

PN-881 Oral Solution Single Ascending Dose

Group Type EXPERIMENTAL

PN-881 Oral Solution

Intervention Type DRUG

PN-881 Oral Solution

Placebo Oral Solution Single Ascending Dose

Placebo single ascending doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

PN-881 Oral Solution Multiple Ascending Dose

PN-881 Multiple Ascending Doses

Group Type EXPERIMENTAL

PN-881 Oral Solution

Intervention Type DRUG

PN-881 Oral Solution

Placebo Oral Solution Multiple Ascending Dose

Placebo, multiple ascending doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

PN-881 Oral Tablet Single Dose

PN-881 oral tablet single dose

Group Type EXPERIMENTAL

PN-881 Oral Tablet

Intervention Type DRUG

PN-881 oral tablet

PN-881 Oral Tablet Multiple Dose

PN-881 oral tablet multiple dose

Group Type EXPERIMENTAL

PN-881 Oral Tablet

Intervention Type DRUG

PN-881 oral tablet

Interventions

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PN-881 Oral Solution

PN-881 Oral Solution

Intervention Type DRUG

PN-881 Oral Tablet

PN-881 oral tablet

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Protagonist Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nucleus Network

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Clinical Study Director

Role: CONTACT

[email protected]
+61 1800 243 733

Facility Contacts

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Clinical Study Director

Role: primary

[email protected]
+61 1800 243 733

Other Identifiers

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PN-881-01

Identifier Type: -

Identifier Source: org_study_id