Healthy VolunteersPhase 1NCT04621630
Pharmacokinetics of PN-235 in Healthy Volunteers
A Phase 1 study testing PN-235 in people with Healthy Volunteers, run by Protagonist Therapeutics, Inc. at 1 site in Australia.
Trial summary
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized, crossover solid dose comparison and effect… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PN-235
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Nov 2020to 13 Oct 2021
- 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
- Subjects must have BMI between 18 and 32
- Subjects must be non-smokers or social smokers
- Subjects must comply with contraception requirements
- Subjects must be willing to consume meals provided by the clinical center
Who cannot join
- Subject must not have history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
- Subjects must not have history of surgical resection of the stomach, small or large intestine
- Subjects must not have fever or symptomatic viral or bacterial infection within 2 weeks of screening
- Subjects must not have corrected QT greater than 450 msec in males and 470 msec in females
- Subjects must not test positive for Hepatitis C or B at Screening
- Subjects must refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized, crossover solid dose comparison and effect of food study.
Read the detailed description
Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses.
Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days.
Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion.
In total, approximately 102 subjects will participate.
- Conditions
- Healthy Volunteers
- Being tested
- PN-235, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN-235Drug
Also called Active Drug
Active Drug
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Dose | Experimental | Single dose administration Receives: Drug: PN-235; Drug: Placebo |
| Multiple Dose | Experimental | Multiple dose administration Receives: Drug: PN-235; Drug: Placebo |
| Solid Dose Comparison | Experimental | Solid dose administartion Receives: Drug: PN-235 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PN-235
Number and severity of Adverse Events
Measured: 10 days
Secondary outcomes (2)
Pharmacokinetics (PK) of PN-235 in plasma
Peak concentration (Cmax) of PN-235
Measured: 10 days
Area Under the Concentration (AUC) of PN-235
AUC over 24 hours on Day 10 for PN-235
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start12 Nov 2020
- Primary completion19 Sep 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 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
- NCT04621630
- Sponsor's protocol ID
- PN-235-01
- Status last verified
- Feb 2022
- First submitted
- 29 Oct 2020
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Knight B, Tammara B, Modi NB, Dallas S, Mardirosian S, Wang J, Laenen A, Leclercq L, DiLoreto K, Adriaenssen L, Moss D, Polidori D, Chaudhuri SR, Park S, Sensenhauser C, Ndifor A, Sukumaran S, Baguet T, Shi Y, Patel S, Geist B, Fourie A, Patch R, Sun C, Barros SA, Somani S, Monshouwer M. Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling. Dermatol Ther (Heidelb). 2025 Sep;15(9):2495-2520. doi: 10.1007/s13555-025-01454-7. Epub 2025 Jul 8.
PubMed 40629250
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04621630
- Acronym / sponsor ID
- PN-235-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Protagonist Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 19 Sep 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 9 Nov 2020 (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.
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized, crossover solid dose comparison and effect of food study.
Detailed description
Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses.
Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days.
Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion.
In total, approximately 102 subjects will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose | Experimental | Drug: PN-235, Drug: PlaceboSingle dose administration |
| Multiple Dose | Experimental | Drug: PN-235, Drug: PlaceboMultiple dose administration |
| Solid Dose Comparison | Experimental | Drug: PN-235Solid dose administartion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have BMI between 18 and 32
- Subjects must be non-smokers or social smokers
- Subjects must comply with contraception requirements
- Subjects must be willing to consume meals provided by the clinical center
Key exclusion criteria (6 listed)
- Subject must not have history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
- Subjects must not have history of surgical resection of the stomach, small or large intestine
- Subjects must not have fever or symptomatic viral or bacterial infection within 2 weeks of screening
- Subjects must not have corrected QT greater than 450 msec in males and 470 msec in females
- Subjects must not test positive for Hepatitis C or B at 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-235Also: Active DrugActive Drug | Drug | Multiple Dose, Single Dose, Solid Dose Comparison |
| PlaceboMatching Placebo | Drug | Multiple Dose, Single Dose |
Primary outcome
Safety of PN-235
Time frame: 10 days
Number and severity of Adverse Events
2 secondary outcomes
Pharmacokinetics (PK) of PN-235 in plasma
Time frame: 10 days
Area Under the Concentration (AUC) of PN-235
Time frame: 10 days
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 18 Feb 2022.
- Derived from this study: PubMed 40629250Knight B, Tammara B, Modi NB, Dallas S, Mardirosian S, Wang J, Laenen A, Leclercq L, DiLoreto K, Adriaenssen L, Moss D, Polidori D, Chaudhuri SR, Park S, Sensenhauser C, Ndifor A, Sukumaran S, Baguet T, Shi Y, Patel S, Geist B, Fourie A, Patch R, Sun C, Barros SA, Somani S, Monshouwer M. Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling. Dermatol Ther (Heidelb). 2025 Sep;15(9):2495-2520. doi: 10.1007/s13555-025-01454-7. Epub 2025 Jul 8.
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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-235 in people with Healthy Volunteers, 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 6 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 18 Feb 2022. 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. 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?
Safety of PN-235 (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621630, which also lists 1 linked publication.
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 18 Feb 2022.