NCT06037395

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Celltrion · Industry
• Sex: Male
• Age: 28 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
BIOLOGICAL	CT-P41	a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
BIOLOGICAL	US-licensed Prolia	a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Timeline

• Start date: 2021-10-06
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2023-09-14
• Last updated: 2023-09-14

Locations

2 sites across 1 country: South Korea