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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Biological: CT-P41
* Biological: EU-approved Prolia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |