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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Biological: CT-P41; Biological: US-licensed Prolia

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Seongnam, Bundang-gu, Korea, Republic of, 13520
      • CHA Bundang Medical Center
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 35015
      • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Celltrion

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: CT-P41
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Denosumab
• Other Study ID Numbers: CT-P41 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No