CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects
Phase 1
Completed
- Conditions
- Health, Subjective
- Registration Number
- NCT03446976
- Lead Sponsor
- Celltrion
- Brief Summary
This study compares two administration methods of CT-P13. Half of participants will receive CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.
- Detailed Description
This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will be enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
Inclusion Criteria
- Healthy male and female subject
- Subject voluntarily agrees to participate in this study
Exclusion Criteria
- Subject with medical history and/or condition
- Female who is pregnant or breastfeeding, or childbearing potential.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects. over 12 weeks Pharmacokinetics will be assessed by AUC
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States
PPD Development, LP🇺🇸Austin, Texas, United States