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

July 25, 2019 updated by: Celltrion

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

218

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Development, LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Biological: CT-P13 SC Pre-filled Syringe
Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
over 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Investigators

  • Study Chair: SuEun Song, Celltrion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2018

Primary Completion (ACTUAL)

July 26, 2018

Study Completion (ACTUAL)

July 26, 2018

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (ACTUAL)

February 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P13 1.9
  • 135134 (OTHER: IND)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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