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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512872
Recruitment Status : Active, not recruiting
First Posted : August 14, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Healthy Male Subjects Biological: CT-P41 Biological: EU-approved Prolia Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512872


Locations
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Australia, Queensland
Q-Pharm Pty Ltd
Herston, Queensland, Australia, 4006
Sponsors and Collaborators
Celltrion
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT04512872    
Other Study ID Numbers: CT-P41 1.1
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs