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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-05-04

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

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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.

Conditions

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Healthy Male Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT-P41

60 mg/mL single dose administration, Solution for injection in PFS

Group Type EXPERIMENTAL

CT-P41

Intervention Type BIOLOGICAL

60 mg/mL single dose, Solution for injection in PFS

EU-approved Prolia

60 mg/mL single dose administration, Solution for injection in PFS

Group Type ACTIVE_COMPARATOR

EU-approved Prolia

Intervention Type BIOLOGICAL

60 mg/mL single dose, Solution for injection in PFS

Interventions

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CT-P41

60 mg/mL single dose, Solution for injection in PFS

Intervention Type BIOLOGICAL

EU-approved Prolia

60 mg/mL single dose, Solution for injection in PFS

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

28 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes