Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
NCT ID: NCT06037395
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
154 participants
INTERVENTIONAL
2021-10-06
2022-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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CT-P41
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
CT-P41
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Prolia
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Prolia
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
Interventions
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CT-P41
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Prolia
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
Eligibility Criteria
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Inclusion Criteria
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
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
28 Years
55 Years
MALE
Yes
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Locations
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CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea
Chungnam National University Hospital
Daejeon, Jung-gu, South Korea
Countries
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References
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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.
Other Identifiers
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CT-P41 1.2
Identifier Type: -
Identifier Source: org_study_id
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