Status:
COMPLETED
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Lead Sponsor:
Celltrion
Conditions:
Healthy Subject
Eligibility:
MALE
28-55 years
Phase:
PHASE1
Brief Summary
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 Subj...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06037395
Start Date
October 6 2021
End Date
October 20 2022
Last Update
September 14 2023
Active Locations (2)
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1
CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea, 13520
2
Chungnam National University Hospital
Daejeon, Jung-gu, South Korea, 35015