Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Study Overview
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Brief Summary
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A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Detailed Description
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This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.

Official Title
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A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Conditions
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Healthy Subject

Intervention / Treatment
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* Biological: CT-P41
* Biological: US-licensed Prolia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject, between the ages of 28 and 55 years, both inclusive Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth. Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin D ≥ 20 ng/mL (≥ 50 nmol/L) Exclusion Criteria: Subject was a female. Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex). Subject was confirmed or suspected with infection of coronavirus disease 2019 (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from screening. Subject had a medical history of and/or current medical condition that can have effect on the study. Details to be discussed with investigator as per Protocol. Subjects with known risk factors for hypocalcaemia Subjects with known intolerance to calcium or vitamin D supplements Subjects with known infection with active hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis Subject had a history of and/or concurrent use of medications including any prior therapy that can have effect on the study. Details to be discussed with investigator as per Protocol. Subjects have or had any therapy that might significantly affect bone metabolism

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
Interventional Model Description: Two-arm, Parallel group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P41<br>a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: CT-P41<br>* a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)<br>|
| Active Comparator: US-licensed Prolia<br>a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: US-licensed Prolia<br>* a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Area under the concentration-time curve from time zero to infinity (AUC0-inf) | up to Day 253 | 
| AUClast | Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) | up to Day 253 | 
| Cmax | maximum serum concentration (Cmax) | up to Day 253 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT-P41