Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-31 @ 9:14 AM
Study NCT ID:
NCT06037395
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2023-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Sponsor:
Celltrion
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: