A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Phase 1
- Conditions
- Healthy Subjects
- Interventions
- Biological: CT-P47Biological: EU-approved RoActemra,
- Registration Number
- NCT05188378
- Lead Sponsor
- Celltrion
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT-P47 CT-P47 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved RoActemra EU-approved RoActemra, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
- Primary Outcome Measures
Name Time Method Primary objective up to Day 43 To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of