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A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P47 | Experimental | 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| EU-approved RoActemra | Active Comparator | 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P47 | Biological | 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary objective | To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf) | up to Day 43 |
| Primary objective | To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) | up to Day 43 |
| Primary objective | To demonstrate PK similarity in terms of Maximum serum concentration (Cmax) | up to Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YeonJu Kim | Contact | 82-32-850-5774 | yeonju.kim2@celltrion.com | |
| KyungMin Park | Contact | 82-32-850-5777 | kyungmin.park@celltrion.com |
| Name | Affiliation | Role |
|---|---|---|
| KyungSang Yu | Seoul National University Hospital | Principal Investigator |
| JaeYong Chung | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37231670 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 30, 2023 | |
| Reset | Feb 8, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 30, 2023 | Feb 8, 2024 |
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| EU-approved RoActemra, | Biological | 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| HyeWon Chung |
| Korea University Guro Hospital |
| Principal Investigator |
| DongSeong Shin | Gachon University Gil Medical Center | Principal Investigator |
| MinKyu Park | Chungbuk National University Hospital | Principal Investigator |
| MinGul Kim | Jeonbuk National University Hospital | Principal Investigator |
| JongLyul Ghim | Inje University | Principal Investigator |