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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose | Experimental | Single dose administration |
|
| Multiple Dose | Experimental | Multiple dose administration |
|
| Solid Dose Comparison | Experimental | Solid dose administartion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN-235 | Drug | Active Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of PN-235 | Number and severity of Adverse Events | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of PN-235 in plasma | Peak concentration (Cmax) of PN-235 | 10 days |
| Area Under the Concentration (AUC) of PN-235 | AUC over 24 hours on Day 10 for PN-235 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Melbourne Clinic | Melbourne | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40629250 | Derived | 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. |
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| ID | Term |
|---|---|
| D000095485 | Bulk Drugs |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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Part 1 blinded, Part 2 blinded, Part 3 unblinded
| Placebo | Drug | Matching Placebo |
|
| 10 days |