CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects
A Phase 1, Randomized, Open-label, Single-dose, Two-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of the Pre-filled Syringe and Auto-injector of CT-P13 in Healthy Subjects
2 other identifiers
interventional
218
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2018
CompletedStudy Start
First participant enrolled
February 21, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2018
CompletedJuly 26, 2019
July 1, 2019
5 months
February 21, 2018
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects.
Pharmacokinetics will be assessed by AUC
over 12 weeks
Study Arms (2)
CT-P13 SC Auto-injector
EXPERIMENTALCT-P13 SC Auto-injector
CT-P13 SC Pre-filled Syringe
EXPERIMENTALCT-P13 SC Pre-filled Syringe
Interventions
Each subject may receive single dose by subcutaneous administration using Auto-Injector
Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe
Eligibility Criteria
You may qualify if:
- Healthy male and female subject
- Subject voluntarily agrees to participate in this study
You may not qualify if:
- Subject with medical history and/or condition
- Female who is pregnant or breastfeeding, or childbearing potential.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celltrionlead
Study Sites (1)
PPD Development, LP
Austin, Texas, 78744, United States
Study Officials
- STUDY CHAIR
SuEun Song
Celltrion
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2018
First Posted
February 27, 2018
Study Start
February 21, 2018
Primary Completion
July 26, 2018
Study Completion
July 26, 2018
Last Updated
July 26, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share