Healthy Subjects
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALCT-P47
CT-P47, 162 mg in 0.9 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
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female subjects between the ages of 19 to 55 years, both inclusive. 2. Subject with a body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth.
Exclusion criteria
1. A medical history and/or condition that is considered significant 2. Clinically significant allergic reactions, hypersensitivity 3. History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis 4. Active or latent Tuberculosis 5. History of malignancy 6. Previous exposure to tocilizumab or any drug that targets IL-6
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK similarity demonstration by AUC | Day 43 | 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. |
| PK similarity demonstration by Cmax | Day 43 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional PK evaluation | Day 43 | Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last). |
| Safety evaluation by TEAEs | Day 43 | Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P47. |
Countries
South Korea
Contacts
Primary ContactMinAh Chun
Backup ContactEnDa Ko
Outcome results
None listed