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

Celltrion218 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

218

Conditions

Health, Subjective

Interventions

CT-P13 SC Auto-injectorBIOLOGICAL

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

CT-P13 SC Pre-filled SyringeBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PPD Development, LP

Austin, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: over 12 weeks

Data from ClinicalTrials.gov

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