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New drug PN-881 enters first human safety tests

NCT ID NCT07153146

Knowledge-focused Sponsor: Protagonist Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug, PN-881, in 142 healthy adults to see if it is safe and how the body processes it. Participants will receive either the drug or a placebo as a single dose or multiple doses. The study is not designed to treat any disease but to gather important safety information for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PN-881

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

146 people

The number who actually took part.

Started

Oct 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteer

Contacts and locations

Locations

  • Nucleus Network

    Melbourne, Victoria, 3004, Australia

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