Phase I Dose escalating study for CT-P27
Not Applicable
Completed
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001179
- Lead Sponsor
- Celltrion
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
1. Subject is healthy male or female, and between 18 and 55 years old (both inclusive).
2. Subject's body mass index (BMI) is of =30.0 kg/m2 and weight is of =50.0 kg.
Exclusion Criteria
1. Subject has a medical condition of disease including endocrine, cardiovascular, infection, cancer, or renal, neurological, hemotologic disease.
2. History or presence of regular alcohol consumption
3. Subject in pregnancy or breastfeeding
4. Veins unsuitable for infusion and/or repeat venipuncture
5. Vulnerable subjects
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability of CT-P27
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of CT-P27 components (CT-P22 and CT-P23);Safety and Tolerability of CT-P27