Healthy Male Subjects
Conditions
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
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.
Interventions
BIOLOGICALCT-P41
60 mg/mL single dose, Solution for injection in PFS
BIOLOGICALEU-approved Prolia
60 mg/mL single dose, Solution for injection in PFS
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
28 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety | 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 |
Countries
Australia
Outcome results
None listed