drugset / Trial / NCT03970824

To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects

Phase 1 Completed 312 enrolled Celltrion

RandomizedParallel-groupQuadruple-blindOther

Summary

This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects

Timeline

Start: 2019-05-31
Primary completion: 2019-11-13
Completion: 2020-01-15

Outcome

Met primary endpoint

paper AUC0-inf , AUC0-last , and Cmax were equivalent among CT-P17, US-adalimumab, and EU-adalimumab PMID 33503313 ↗

registry analysis (equivalence test); CT-P17 vs US-licensed Humira; Ratio of geometric least squares means 105.79 (90% CI 97.19 to 115.16) NCT03970824 ↗

registry analysis (equivalence test); CT-P17 vs EU-approved Humira; Ratio of geometric least squares means 98.00 (90% CI 90.06 to 106.63) NCT03970824 ↗

registry analysis (equivalence test); CT-P17 vs US-licensed Humira; Ratio of geometric least squares means 107.30 (90% CI 98.29 to 117.13) NCT03970824 ↗

registry analysis (equivalence test); CT-P17 vs EU-approved Humira; Ratio of geometric least squares means 100.79 (90% CI 92.42 to 109.92) NCT03970824 ↗

registry analysis (equivalence test); CT-P17 vs US-licensed Humira; Ratio of geometric least squares means 101.89 (90% CI 95.33 to 108.89) NCT03970824 ↗

registry analysis (equivalence test); CT-P17 vs EU-approved Humira; Ratio of geometric least squares means 100.05 (90% CI 93.69 to 106.85) NCT03970824 ↗

Publications

Yu KS, Jang IJ, Lim HS, Hong JH, Kim MG, Park MK, Cho DY, Park MS, Chung JY, Ghim JL, Lee S, Yoon SK, Kwon IS, Lee SJ, Kim SH, Bae YJ, Cha JB, Furst DE, Keystone E, Kay J. Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clin Transl Sci. 2021 Jul;14(4):1280-1291. doi: 10.1111/cts.12967. Epub 2021 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	CT-P17	Monoclonal antibody	40 mg	Subcutaneous

Indications

No indication recorded.