Pharmacokinetics of PN-235 in Healthy Volunteers

Phase 1 Completed 107 enrolled Protagonist Therapeutics, Inc.

RandomizedSequentialTriple-blindTreatment

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 of food study.

Timeline

Start: 2020-11-12
Primary completion: 2021-09-19
Completion: 2021-10-13

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Icotrokinra	Peptide	—	Oral

Indications

No indication recorded.