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

NCT03446976 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2019-07-26

No results posted yet for this study

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.

Conditions

  • Health, Subjective

Interventions

BIOLOGICAL

CT-P13 SC Auto-injector

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

BIOLOGICAL

CT-P13 SC Pre-filled Syringe

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

Sponsors & Collaborators

Principal Investigators

  • SuEun Song · Celltrion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2018-07-26
Completion
2018-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446976 on ClinicalTrials.gov