Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule

Phase 1 Completed 55 enrolled RANI Therapeutics

Non-randomizedParallel-groupOpen-labelTreatment

Summary

A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPill™ capsule ("RT-111").

Timeline

Start: 2023-08-30
Primary completion: 2023-11-28
Completion: 2023-11-28

Publications

Myers JT, Yamaguchi A, Horlen K, Fung LC, Vo AT, Mohan D, Hoopes M, Imran M, Van Dam J, Gonen OM, Hashim MA, Dhalla AK, Blauvelt A. Oral delivery of an ustekinumab biosimilar with bioavailability comparable to subcutaneous administration in healthy human participants. Eur J Clin Pharmacol. 2026 Jan 19;82(2):40. doi: 10.1007/s00228-025-03969-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ustekinumab	Monoclonal antibody	0.5 mg	Subcutaneous
Subject	Ustekinumab	Monoclonal antibody	0.5 mg	Oral
Subject	Ustekinumab	Monoclonal antibody	0.75 mg	Oral

Indications

No indication recorded.