To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
NCT ID: NCT03970824
Last Updated: 2021-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
312 participants
INTERVENTIONAL
2019-05-31
2020-01-15
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-P17
a single subcutaneous (SC) injection via pre-filled syringe (PFS)
CT-P17
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
US-licensed Humira
a single subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
EU-approved Humira
a single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Interventions
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CT-P17
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
US-licensed Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
EU-approved Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Eligibility Criteria
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Inclusion Criteria
* BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth
Exclusion Criteria
* Clinically significant allergic reactions, hypersensitivity
* History or current infection of hepatitis B virus (except for past resolved infection), hepatitis C virus, human immunodeficiency virus, or syphilis
* Active or latent Tuberculosis
* History of malignancy
* Previous monoclonal antibody or fusion protein treatment, or current use of any biologic
* Planning to be pregnant or father a child or donate sperm within 5 month after administration
* Undergone treatment with an investigational drug or participated in another clinical trial within 90 days or 5 half-lives (whichever is longer)
19 Years
55 Years
ALL
Yes
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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Sang Joon Lee
Role: STUDY_DIRECTOR
Celltrion, Inc.
Locations
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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References
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Yu KS, Jang IJ, Lim HS, Hong JH, Kim MG, Park MK, Cho DY, Park MS, Chung JY, Ghim JL, Lee S, Yoon SK, Kwon IS, Lee SJ, Kim SH, Bae YJ, Cha JB, Furst DE, Keystone E, Kay J. Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clin Transl Sci. 2021 Jul;14(4):1280-1291. doi: 10.1111/cts.12967. Epub 2021 Mar 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CT-P17 1.1
Identifier Type: -
Identifier Source: org_study_id