NCT03446976

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health, Subjective

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-02-21
• Primary completion: 2018-07-26
• Completion: 2018-07-26
• First posted: 2018-02-27
• Last updated: 2019-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study