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
Not Applicable
- Conditions
- Not Applicable
- Registration Number
- KCT0007816
- Lead Sponsor
- Celltrion
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 268
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and maximum serum concentration (Cmax) of CT-P47 SC administration via AI versus PFS in healthy subjects
- Secondary Outcome Measures
Name Time Method To evaluate additional PK, safety, and immunogenicity of CT-P47 SC administration via AI versus PFS in healthy subjects