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

Celltrion Healthcare

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Biological: EU-approved Prolia

Biological: CT-P41

Study type

Interventional

Funder types

Industry

Identifiers

NCT04512872

CT-P41 1.1

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

Male

Ages

28 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.