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

NCT ID: NCT03446976

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2018-07-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Health, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CT-P13 SC Auto-injector

CT-P13 SC Auto-injector

Group Type EXPERIMENTAL

CT-P13 SC Auto-injector

Intervention Type BIOLOGICAL

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

CT-P13 SC Pre-filled Syringe

CT-P13 SC Pre-filled Syringe

Group Type EXPERIMENTAL

CT-P13 SC Pre-filled Syringe

Intervention Type BIOLOGICAL

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

Interventions

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CT-P13 SC Auto-injector

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

Intervention Type BIOLOGICAL

CT-P13 SC Pre-filled Syringe

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celltrion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SuEun Song

Role: STUDY_CHAIR

Celltrion

Locations

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PPD Development, LP

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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135134

Identifier Type: OTHER

Identifier Source: secondary_id

CT-P13 1.9

Identifier Type: -

Identifier Source: org_study_id

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