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

Phase 1

Completed

• Conditions: Health, Subjective
• Interventions: Biological: CT-P13 SC Auto-injector; Biological: CT-P13 SC Pre-filled Syringe

• Registration Number: NCT03446976
• Lead Sponsor: Celltrion

Brief 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.

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 Timeline

• Study Start: 2018-02-21
• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13 SC Auto-injector	CT-P13 SC Auto-injector	CT-P13 SC Auto-injector
CT-P13 SC Pre-filled Syringe	CT-P13 SC Pre-filled Syringe	CT-P13 SC Pre-filled Syringe

Primary Outcome Measures

Name	Time	Method
To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects.	over 12 weeks	Pharmacokinetics will be assessed by AUC

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States