A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
NCT ID: NCT05188378
Last Updated: 2022-01-12
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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UNKNOWN
PHASE1
300 participants
INTERVENTIONAL
2021-12-22
2023-01-31
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-P47
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
CT-P47
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved RoActemra
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved RoActemra,
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Interventions
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CT-P47
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved RoActemra,
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Eligibility Criteria
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Inclusion Criteria
* Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 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, hepatitis C virus, human immunodeficiency virus, or syphilis
* Active or latent Tuberculosis
* History of malignancy
* Previous exposure to tocilizumab or any drug that targets IL-6
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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KyungSang Yu
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
JaeYong Chung
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
HyeWon Chung
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
DongSeong Shin
Role: PRINCIPAL_INVESTIGATOR
Gachon University Gil Medical Center
MinKyu Park
Role: PRINCIPAL_INVESTIGATOR
Chungbuk National University Hospital
MinGul Kim
Role: PRINCIPAL_INVESTIGATOR
Jeonbuk National University Hospital
JongLyul Ghim
Role: PRINCIPAL_INVESTIGATOR
Inje University
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Kyungsang Yu
Role: primary
References
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Yu KS, Kim B, Shin D, Park MK, Hwang JG, Kim MG, Chung H, Ghim J, Chung JY, Smolen JS, Burmester GR, Kim S, Bae Y, Jeon D, Yoo J, Yang G, Bae J, Keystone E. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study. Expert Opin Investig Drugs. 2023 May;32(5):429-439. doi: 10.1080/13543784.2023.2212155. Epub 2023 May 26.
Other Identifiers
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CT-P47 1.1
Identifier Type: -
Identifier Source: org_study_id
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