Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

Study Overview
=================
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.

Official Title
-----------------
A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: CT-P47
* Biological: CT-P47


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects between the ages of 19 to 55 years, both inclusive. 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: 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 tocilizumab or any drug that targets IL-6

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P47 Auto-injector<br>CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI) | Biological: CT-P47<br>* CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI)<br>|
| Active Comparator: CT-P47 Pre-filled Syringe<br>CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: CT-P47<br>* CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK similarity demonstration by AUC | 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. | Day 43 | 
| PK similarity demonstration by Cmax | 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. | Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional PK evaluation | Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last). | Day 43 | 
| Safety evaluation by TEAEs | Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P47. | Day 43 |