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This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.
CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate the pharmacokinetics and safety of the Auto-injector and Pre-filled syringe of CT-P47 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P47 Auto-injector | Experimental | CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI) |
|
| CT-P47 Pre-filled Syringe | Active Comparator | CT-P47, 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 | CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK similarity demonstration by AUC | Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P47 SC administration via AI versus PFS in healthy subjects up to Day 43. The similarity of PK between CT-P47 AI vs CT-P47 PFS will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for AUC0-inf. | Day 43 |
| PK similarity demonstration by Cmax | Demonstrate PK similarity in terms of maximum serum concentration (Cmax) of CT-P47 SC administration via AI versus PFS in healthy subjects up to Day 43. The similarity of PK between CT-P47 AI vs CT-P47 PFS will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for Cmax. | Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional PK evaluation | Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last). | Day 43 |
| Safety evaluation by TEAEs | Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P47. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MinAh Chun | Contact | +82 32 850 5761 | minah.chun@celltrion.com | |
| EnDa Ko | Contact | +82 32 850 5757 | enda.ko@celltrion.com |
| Name | Affiliation | Role |
|---|---|---|
| KyungSang Yu | Seoul National University College of Medicine and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38905143 | Derived | Yu KS, Ryu H, Shin D, Park M, Hwang J, Moon SJ, Kim MG, Keystone E, Smolen JS, Kim S, Bae Y, Jeon D, Jang J, Yang G, Bae J, Lee J, Burmester GR. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open-label, single-dose phase I study. Expert Opin Biol Ther. 2024 Jul;24(7):681-689. doi: 10.1080/14712598.2024.2321360. Epub 2024 Jun 21. |
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| CT-P47 | Biological | CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| Day 43 |