Healthy Male Subjects
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALCT-P43
CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects, between the ages of 19 and 55 years, both inclusive. * Subject has a body weight between 60 to 90 kg, both inclusive, and a 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 hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis * Active or latent Tuberculosis * History of malignancy * Previous exposure to ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK similarity demonstration by AUC 0-inf | Day113 | 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). |
| PK similarity demonstration by Cmax | Day113 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional PK evaluation | Day113 | 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). |
| Safety evaluation by AEs | Day113 | Evaluate safety in terms of adverse events (including treatment-emergent adverse events \[TEAEs\] and serious adverse events\[SAEs\]). |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHyewon Chung
Korea University Guro Hospital (Department of Clinical Pharmacology)
Outcome results
None listed