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

August 31, 2021 updated by: Celltrion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Q-Pharm Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-P41
60 mg/mL single dose administration, Solution for injection in PFS
Biological: CT-P41
60 mg/mL single dose, Solution for injection in PFS
Active Comparator: EU-approved Prolia
60 mg/mL single dose administration, Solution for injection in PFS
Biological: EU-approved Prolia
60 mg/mL single dose, Solution for injection in PFS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety
Time Frame: 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
through study completion, up to day 134

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Actual)

May 4, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P41 1.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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