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This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects
CT-P55, containing the active ingredient secukinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Cosentyx. In this study, Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx were evaluated in Healthy Male Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P55 | Experimental | a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| US-licensed Cosentyx | Active Comparator | a single SC injection via PFS |
|
| EU-approved Cosentyx | Active Comparator | a single SC injection via PFS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P55 | Biological | 150 mg in 1.0 mL, administered as a single SC injection via PFS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) | Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P55, European Union (EU)-approved Cosentyx and United States (US)-licensed Cosentyx in healthy male subjects. The similarity of PK 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 155 |
| PK similarity demonstration in terms of maximum serum concentration (Cmax) | Demonstrate PK similarity in terms of Cmax of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in healthy male subjects up to Day 155. The similarity of PK 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 155 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last) | Day 155 | |
| Evaluate additional PK in terms of Time to Cmax (Tmax) | Day155 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoko Hasunuma | Kitasato University Kitasato Institute Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama Minoru Clinic | Yokohama | Kanagawa | 232-0064 | Japan | ||
| SOUSEIKAI Nishikumamoto Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41665131 | Derived | Hasunuma T, Yagi M, Nakamichi N, Blauvelt A, Thaci D, Suh J, Cha J, Noh I, Lee E, Papp KA. Pharmacokinetics and safety of candidate biosimilar CT-P55 versus reference secukinumab: a three-arm, randomized, double-blinded, single-dose, multicenter, Phase I study. Expert Opin Investig Drugs. 2026 Jan-Feb;35(2):179-188. doi: 10.1080/13543784.2026.2628208. Epub 2026 Feb 22. |
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| US-licensed Cosentyx |
| Biological |
150 mg in 1.0 mL, administered as a single SC injection via PFS |
|
| EU-approved Cosentyx | Biological | 150 mg in 1.0 mL, administered as a single SC injection via PFS |
|
| Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F) |
| Day 155 |
| Evaluate additional PK in terms of Terminal elimination rate constant (λz) | Day155 |
| Evaluate additional PK in terms of Terminal elimination half-life (t1/2) | Day 155 |
| Evaluate additional PK in terms of Apparent total body clearance (CL/F) | Day155 |
| Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap) | Day 155 |
| Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P55 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Day 155 |
| Kumamoto |
| Kumamoto |
| Japan |
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | Osaka | 532-0003 | Japan |
| Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo | 108-8642 | Japan |