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This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 in Healthy Male Subjects.
CT-P43, containing the active ingredient ustekinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Stelara. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 will be evaluated in Healthy Male Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P43 Auto-injector | Experimental | CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI) |
|
| CT-P43 Pre-filled syringe | Active Comparator | CT-P43, 45 mg in 0.5 ml, a single SC injection via pre-filled syringe (PFS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P43 | Biological | CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK similarity demonstration by AUC 0-inf | Demonstrate the PK similarity in terms of area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16). | Day113 |
| PK similarity demonstration by Cmax | Demonstrate the PK similarity in terms of maximum serum concentration (Cmax) of CT-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16). | Day113 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional PK evaluation | Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last). Time to maximum concentration (Tmax), Terminal half-life (t1/2), Percentage of AUC0-inf obtained by extrapolation (%AUCextrap). | Day113 |
| Safety evaluation by AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyewon Chung | Korea University Guro Hospital (Department of Clinical Pharmacology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Guro-gu | 08308 | South Korea |
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| CT-P43 | Biological | CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
Evaluate safety in terms of adverse events (including treatment-emergent adverse events [TEAEs] and serious adverse events[SAEs]). |
| Day113 |