Healthy VolunteerPhase 1NCT07153146
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
A Phase 1 study testing PN-881 Oral Solution and PN-881 Oral Tablet in people with Healthy Volunteer, run by Protagonist Therapeutics, Inc. at 1 site in Australia.
Trial summary
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- PN-881 Oral Solution and PN-881 Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Oct 2025to 29 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
Read the detailed description
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
- Healthy Volunteer
- Being tested
- PN-881 Oral Solution, PN-881 Oral Tablet, Placebo
- Keywords
- PN-881
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN-881 Oral SolutionDrug
PN-881 Oral Solution
PN-881 Oral TabletDrug
PN-881 oral tablet
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PN-881 Oral Solution Single Ascending Dose | Experimental | PN-881 Oral Solution Single Ascending Dose Receives: Drug: PN-881 Oral Solution |
| Placebo Oral Solution Single Ascending Dose | Placebo comparator | Placebo single ascending doses Receives: Drug: Placebo |
| PN-881 Oral Solution Multiple Ascending Dose | Experimental | PN-881 Multiple Ascending Doses Receives: Drug: PN-881 Oral Solution |
| Placebo Oral Solution Multiple Ascending Dose | Placebo comparator | Placebo, multiple ascending doses Receives: Drug: Placebo |
| PN-881 Oral Tablet Single Dose | Experimental | PN-881 oral tablet single dose Receives: Drug: PN-881 Oral Tablet |
| PN-881 Oral Tablet Multiple Dose | Experimental | PN-881 oral tablet multiple dose Receives: Drug: PN-881 Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Predose to 7 days after last dose
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax) of PN-881
Highest measured plasma concentration of PN-881 following oral administration.
Measured: 48 hours following the first dose and the last dose
Area under the plasma concentration-time curve (AUC) of PN-881
AUC calculated from 0 to infinity.
Measured: Predose to 48 hours after the first and last dose.
Levels of biomarker in serum
Pharmacodynamics (PD) of PN-881 by means of increase in levels of biomarker by PN-881 after single and multiple oral doses.
Measured: Day 1 Predose up to 48 hours post (last) dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start7 Oct 2025
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protagonist Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153146
- Sponsor's protocol ID
- PN-881-01
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Phase I study
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07153146
- Acronym / sponsor ID
- PN-881-01
- Conditions
- Healthy Volunteer
- Keywords
- PN-881
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Protagonist Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PN-881 Oral Solution Single Ascending Dose | Experimental | Drug: PN-881 Oral SolutionPN-881 Oral Solution Single Ascending Dose |
| Placebo Oral Solution Single Ascending Dose | Placebo comparator | Drug: PlaceboPlacebo single ascending doses |
| PN-881 Oral Solution Multiple Ascending Dose | Experimental | Drug: PN-881 Oral SolutionPN-881 Multiple Ascending Doses |
| Placebo Oral Solution Multiple Ascending Dose | Placebo comparator | Drug: PlaceboPlacebo, multiple ascending doses |
| PN-881 Oral Tablet Single Dose | Experimental | Drug: PN-881 Oral TabletPN-881 oral tablet single dose |
| PN-881 Oral Tablet Multiple Dose | Experimental | Drug: PN-881 Oral TabletPN-881 oral tablet multiple dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PN-881 Oral SolutionPN-881 Oral Solution | Drug | PN-881 Oral Solution Multiple Ascending Dose, PN-881 Oral Solution Single Ascending Dose |
| PN-881 Oral TabletPN-881 oral tablet | Drug | PN-881 Oral Tablet Multiple Dose, PN-881 Oral Tablet Single Dose |
| PlaceboPlacebo | Drug | Placebo Oral Solution Multiple Ascending Dose, Placebo Oral Solution Single Ascending Dose |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 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.
3 secondary outcomes
Maximum observed plasma concentration (Cmax) of PN-881
Time frame: 48 hours following the first dose and the last dose
Area under the plasma concentration-time curve (AUC) of PN-881
Time frame: Predose to 48 hours after the first and last dose.
Levels of biomarker in serum
Time frame: Day 1 Predose up to 48 hours post (last) dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Phase I study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PN-881 Oral Solution and PN-881 Oral Tablet in people with Healthy Volunteer, run by Protagonist Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Predose to 7 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.