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

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512872
• Other study ID #: CT-P41 1.1
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: August 2021
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 28 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Biological:
• CT-P41
60 mg/mL single dose, Solution for injection in PFS
• EU-approved Prolia
60 mg/mL single dose, Solution for injection in PFS

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety	safety in terms of treatment-emergent adverse events (TEAEs) of CT-P41 compared to that of EU-approved Prolia	through study completion, up to day 134