NCT04512872

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

A Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Celltrion · Industry
• Sex: Male
• Age: 28 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

Detailed description

This study is a pilot phase 1, randomized, double-blind, two-arm, parallel group, single-dose study, which is designed to evaluate the safety, immunogenicity, PK and PD of CT-P41 and EU-approved Prolia in healthy male subjects. Approximately 30 male subjects will be enrolled and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment group, all subjects will receive a single 60 mg dose of either CT P41 or EU-approved Prolia by subcutaneous injection via a PFS on Day 1, followed by 134 days of safety, immunogenicity, PK, and PD measurements.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
BIOLOGICAL	CT-P41	60 mg/mL single dose, Solution for injection in PFS
BIOLOGICAL	EU-approved Prolia	60 mg/mL single dose, Solution for injection in PFS

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2020-08-14
• Last updated: 2021-09-01

Locations

1 site across 1 country: Australia