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

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Biological: EU-approved Prolia; Biological: CT-P41

• Registration Number: NCT04512872
• Lead Sponsor: Celltrion

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-14
• Study Start: 2020-10-20
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Healthy male subjects, between the ages of 28 and 55 years.
• Subject with a BMI between 18.5 and 29.9 kg/m2.
• Subject with albumin-adjusted total serum calcium ≥8.5 mg/dL (≥2.125 mol/L) and serum 25-OH vitamin D ≥20 ng/ml.
• Male subject and their female partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 5 months after the study drug administration.

Exclusion Criteria

• Subject with a hypersensitivity to any component of denosumab.
• Subject has a history of and/or current known risk factors for hypocalcemia and osteonecrosis of jaw, and any clinically significant illness at investigator's discretion.
• Subject has a history of and/or concurrent use of medications such as an investigational drug, monoclonal antibody, fusion protein, and biologics.
• Subject has a history of and/or concurrent use of any therapy that might significantly affect bone metabolism.
• Subject is vulnerable.
• Subject is not likely to complete the study for whatever reason in the opinion of the Investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EU-approved Prolia	EU-approved Prolia	60 mg/mL single dose administration, Solution for injection in PFS
CT-P41	CT-P41	60 mg/mL single dose administration, Solution for injection in PFS

Primary Outcome Measures

Name	Time	Method
Evaluate safety	through study completion, up to day 134	safety in terms of treatment-emergent adverse events (TEAEs) of CT-P41 compared to that of EU-approved Prolia

Trial Locations

Locations (1)

Q-Pharm Pty Ltd; 🇦🇺 Herston, Queensland, Australia