drugset

drugset / Trial / NCT05617183

Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

NCT05617183 ↗

Phase 1 Unknown 268 enrolled Celltrion

RandomizedParallel-groupOpen-labelOther

Summary

This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.

Timeline

Start: 2022-11-15
Primary completion: 2023-04
Completion: 2023-09

Publications

Yu KS, Ryu H, Shin D, Park M, Hwang J, Moon SJ, Kim MG, Keystone E, Smolen JS, Kim S, Bae Y, Jeon D, Jang J, Yang G, Bae J, Lee J, Burmester GR. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open-label, single-dose phase I study. Expert Opin Biol Ther. 2024 Jul;24(7):681-689. doi: 10.1080/14712598.2024.2321360. Epub 2024 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	CT-P47	Monoclonal antibody	162 mg	Subcutaneous

Indications

No indication recorded.