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CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03446976
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Health, Subjective Biological: CT-P13 SC Auto-injector Biological: CT-P13 SC Pre-filled Syringe Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : February 21, 2018
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : July 26, 2018

Arm Intervention/treatment
Experimental: CT-P13 SC Auto-injector
CT-P13 SC Auto-injector
Biological: CT-P13 SC Auto-injector
Each subject may receive single dose by subcutaneous administration using Auto-Injector

Experimental: CT-P13 SC Pre-filled Syringe
CT-P13 SC Pre-filled Syringe
Biological: CT-P13 SC Pre-filled Syringe
Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe




Primary Outcome Measures :
  1. To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects. [ Time Frame: over 12 weeks ]
    Pharmacokinetics will be assessed by AUC



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446976


Locations
United States, Texas
PPD Development, LP
Austin, Texas, United States, 78744
Sponsors and Collaborators
Celltrion
Investigators
Study Chair: SuEun Song Celltrion

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03446976     History of Changes
Other Study ID Numbers: CT-P13 1.9
135134 ( Other Identifier: IND )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No