Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Healthy Subject Clinical Trial

Official title:

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 Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06037395
• Other study ID #: CT-P41 1.2
• Status: Completed
• Phase: Phase 1
• Start date: October 6, 2021
• Est. completion date: October 20, 2022

Study information

• Verified date: August 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Subjects

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 male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 28 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy male subject, between the ages of 28 and 55 years, both inclusive

2. 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.

3. 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 Criteria:

1. Subject was a female.

2. Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex).

3. 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.

4. 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.

1. Subjects with known risk factors for hypocalcaemia

2. Subjects with known intolerance to calcium or vitamin D supplements

3. Subjects with known infection with active hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis

5. 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.

6. Subjects have or had any therapy that might significantly affect bone metabolism

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Biological:
• CT-P41
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
• US-licensed Prolia
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon	Jung-gu
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Bundang-gu

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf	Area under the concentration-time curve from time zero to infinity (AUC0-inf)	up to Day 253
Primary	AUClast	Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)	up to Day 253
Primary	Cmax	maximum serum concentration (Cmax)	up to Day 253