Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04512872




Registration number
NCT04512872
Ethics application status
Date submitted
11/08/2020
Date registered
14/08/2020
Date last updated
1/09/2021

Titles & IDs
Public title
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Scientific title
A Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Secondary ID [1] 0 0
CT-P41 1.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Male Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CT-P41
Treatment: Other - EU-approved Prolia

Experimental: CT-P41 - 60 mg/mL single dose administration, Solution for injection in PFS

Active comparator: EU-approved Prolia - 60 mg/mL single dose administration, Solution for injection in PFS


Treatment: Other: CT-P41
60 mg/mL single dose, Solution for injection in PFS

Treatment: Other: EU-approved Prolia
60 mg/mL single dose, Solution for injection in PFS
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate safety
Timepoint [1] 0 0
through study completion, up to day 134

Eligibility
Key inclusion criteria
* Healthy male subjects, between the ages of 28 and 55 years.
* Subject with a BMI between 18.5 and 29.9 kg/m2.
* Subject with albumin-adjusted total serum calcium =8.5 mg/dL (=2.125 mol/L) and serum 25-OH vitamin D =20 ng/ml.
* Male subject and their female partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 5 months after the study drug administration.
Minimum age
28 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Subject with a hypersensitivity to any component of denosumab.
* Subject has a history of and/or current known risk factors for hypocalcemia and osteonecrosis of jaw, and any clinically significant illness at investigator's discretion.
* Subject has a history of and/or concurrent use of medications such as an investigational drug, monoclonal antibody, fusion protein, and biologics.
* Subject has a history of and/or concurrent use of any therapy that might significantly affect bone metabolism.
* Subject is vulnerable.
* Subject is not likely to complete the study for whatever reason in the opinion of the Investigator.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/05/2021
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celltrion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Trial website
https://clinicaltrials.gov/study/NCT04512872
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04512872