Healthy Subjects
Conditions
Brief summary
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Detailed description
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.
Interventions
BIOLOGICALCT-P47
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
BIOLOGICALEU-approved RoActemra,
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary objective | up to Day 43 | To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf) |
Countries
South Korea
Contacts
Primary ContactYeonJu Kim
Backup ContactKyungMin Park
Outcome results
None listed