Healthy Male Subjects
Conditions
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALCT-P55
150 mg in 1.0 mL, administered as a single SC injection via PFS
BIOLOGICALUS-licensed Cosentyx
150 mg in 1.0 mL, administered as a single SC injection via PFS
BIOLOGICALEU-approved Cosentyx
150 mg in 1.0 mL, administered as a single SC injection via PFS
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects between the ages of 18 and 55 years, both inclusive. * Body weight between 50.0 kg and 90.0 kg (both inclusive), and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive), when rounded to the nearest tenth.
Exclusion criteria
* A medical history and/or condition that is considered significant * Clinically significant allergic reactions, hypersensitivity * History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis * Active or latent Tuberculosis * History of malignancy * Previous monoclonal antibody or fusion protein treatment, or current use of any biologics * Planning to be father a child or donate sperm within 22 weeks period following study drug administration. * Undergone treatment with an investigational drug or participated in another clinical trial within 12weeks or 5 half-lives (whichever is longer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) | Day 155 | 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. |
| PK similarity demonstration in terms of maximum serum concentration (Cmax) | Day 155 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 AUC from time zero to the last quantifiable concentration (AUC0-last) | Day 155 |
| 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 |
| Evaluate additional PK in terms of Apparent total body clearance (CL/F) | Day155 |
| Evaluate additional PK in terms of Time to Cmax (Tmax) | Day155 |
Countries
Japan
Outcome results
None listed