Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT06037395
Brief 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
Detailed Description:
This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.
Study:
NCT06037395
Study Brief:
Protocol Section:
NCT06037395