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drugset / Trial / NCT05188378

A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

NCT05188378 ↗

Phase 1 Unknown 300 enrolled Celltrion

RandomizedParallel-groupQuadruple-blindOther

Summary

A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Timeline

Start: 2021-12-22
Primary completion: 2022-10-01
Completion: 2023-01-31

Publications

Yu KS, Kim B, Shin D, Park MK, Hwang JG, Kim MG, Chung H, Ghim J, Chung JY, Smolen JS, Burmester GR, Kim S, Bae Y, Jeon D, Yoo J, Yang G, Bae J, Keystone E. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study. Expert Opin Investig Drugs. 2023 May;32(5):429-439. doi: 10.1080/13543784.2023.2212155. Epub 2023 May 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CT-P47	Monoclonal antibody	162 mg	—
Comparator	Tocilizumab	Monoclonal antibody	162 mg	—

Indications

No indication recorded.