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OpenTrials
Completed

NCT Number: NCT03446976

CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector 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.

Completed

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Key information

Conditions

Health, Subjective

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT-P13 SC Auto-Injector

Biological

Each subject may receive single dose by subcutaneous administration using Auto-Injector

CT-P13 SC Pre-filled Syringe

Biological

Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe

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.

    Time frame: over 12 weeks

    Pharmacokinetics will be assessed by AUC

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2018
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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