NCT06037395

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

September 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

September 7, 2023

Last Update Submit

September 7, 2023

Conditions

Healthy Subject

Keywords

CT-P41

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

CT-P41

EXPERIMENTAL

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

Biological: CT-P41

US-licensed Prolia

ACTIVE COMPARATOR

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

Biological: US-licensed Prolia

Interventions

CT-P41BIOLOGICAL

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

CT-P41
US-licensed ProliaBIOLOGICAL

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

US-licensed Prolia

Eligibility Criteria

Age28 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHA Bundang Medical Center

Seongnam, Bundang-gu, 13520, South Korea

Location

Chungnam National University Hospital

Daejeon, Jung-gu, 35015, South Korea

Location

Related Publications (1)

  • Kim A, Hong JH, Shin W, Yoo H, Jung JG, Reginster JY, Kim S, Bae Y, Suh J, Kim S, Lee E, Silverman S. A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT-P41 and reference denosumab in healthy males. Expert Opin Biol Ther. 2024 Jul;24(7):655-663. doi: 10.1080/14712598.2024.2316846. Epub 2024 Feb 22.

    PMID: 38349618DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A Randomized, Double-blind
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two-arm, Parallel group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 14, 2023

Study Start

October 6, 2021

Primary Completion

October 20, 2022

Study Completion

October 20, 2022

Last Updated

September 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)