Status:
COMPLETED
CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects
Lead Sponsor:
Celltrion
Conditions:
Health, Subjective
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy male and female subject
- Subject voluntarily agrees to participate in this study
Exclusion
- Subject with medical history and/or condition
- Female who is pregnant or breastfeeding, or childbearing potential.
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2018
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT03446976
Start Date
February 21 2018
End Date
July 26 2018
Last Update
July 26 2019
Active Locations (1)
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1
PPD Development, LP
Austin, Texas, United States, 78744