Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Phase 1 Completed 154 enrolled Celltrion

RandomizedParallel-groupQuadruple-blindOther

Summary

A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Timeline

Start: 2021-10-06
Primary completion: 2022-10-20
Completion: 2022-10-20

Outcome

Met primary endpoint

paper Ninety percent CIs for ratios of gLSMs were within the predefined equivalence margin for AUC0-inf (100.4-114.7), AUC0-last (99.9-114.3), and Cmax (95.2-107.3). PMID 38349618 ↗

Publications

Kim A, Hong JH, Shin W, Yoo H, Jung JG, Reginster JY, Kim S, Bae Y, Suh J, Kim S, Lee E, Silverman S. A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT-P41 and reference denosumab in healthy males. Expert Opin Biol Ther. 2024 Jul;24(7):655-663. doi: 10.1080/14712598.2024.2316846. Epub 2024 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CT-P41	Unknown	60 mg	Subcutaneous
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous

Indications

No indication recorded.