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

Sponsor

Celltrion (Industry)

Overall Status

Completed

CT.gov ID

NCT06037395

Collaborator

(none)

154

Enrollment

Locations

Arms

12.5

Actual Duration (Months)

Patients Per Site

6.2

Patients Per Site Per Month

Study Details

Study Description

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 Subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy Subject	Biological: CT-P41 Biological: US-licensed Prolia	Phase 1

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two-arm, Parallel groupTwo-arm, Parallel group

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

A Randomized, Double-blind

Primary Purpose:

Other

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

Actual Study Start Date :

Oct 6, 2021

Actual Primary Completion Date :

Oct 20, 2022

Actual Study Completion Date :

Oct 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-P41 a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)	Biological: CT-P41 a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
Active Comparator: US-licensed Prolia a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)	Biological: US-licensed Prolia a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Arm

Intervention/Treatment

Experimental: CT-P41

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: CT-P41

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Active Comparator: US-licensed Prolia

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: US-licensed Prolia

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Outcome Measures

Primary Outcome Measures

AUCinf [up to Day 253]
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
AUClast [up to Day 253]
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Cmax [up to Day 253]
maximum serum concentration (Cmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHA Bundang Medical Center	Seongnam	Bundang-gu	Korea, Republic of	13520
2	Chungnam National University Hospital	Daejeon	Jung-gu	Korea, Republic of	35015

Sponsors and Collaborators

Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celltrion

ClinicalTrials.gov Identifier:

NCT06037395

Other Study ID Numbers:

CT-P41 1.2

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Celltrion

CT-P41

Additional relevant MeSH terms:

Denosumab

Study Results

No Results Posted as of Sep 14, 2023