Status:
COMPLETED
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Lead Sponsor:
Celltrion
Conditions:
Healthy Male Subjects
Eligibility:
MALE
28-55 years
Phase:
PHASE1
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 Subject...
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 Proli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04512872
Start Date
October 20 2020
End Date
May 4 2021
Last Update
September 1 2021
Active Locations (1)
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1
Q-Pharm Pty Ltd
Herston, Queensland, Australia, 4006