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

Phase 1

Completed

• Conditions: Healthy Subject
• Interventions: Biological: CT-P41; Biological: US-licensed Prolia

• Registration Number: NCT06037395
• Lead Sponsor: Celltrion

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

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 Timeline

• Study Start: 2021-10-06
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-20
• Status Verified: 2023-08
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P41	CT-P41	a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Prolia	US-licensed Prolia	a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Primary Outcome Measures

Name	Time	Method
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)
AUCinf	up to Day 253	Area under the concentration-time curve from time zero to infinity (AUC0-inf)

Trial Locations

Locations (2)

Chungnam National University Hospital; 🇰🇷 Daejeon, Jung-gu, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Seongnam, Bundang-gu, Korea, Republic of