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

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Health, Subjective

Treatments: Biological: CT-P13 SC Auto-injector; Biological: CT-P13 SC Pre-filled Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT03446976

CT-P13 1.9

135134 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

CT-P13 SC Auto-injector

Experimental group

Description:

CT-P13 SC Auto-injector

Treatment:

Biological: CT-P13 SC Auto-injector

CT-P13 SC Pre-filled Syringe

Experimental group

Description:

CT-P13 SC Pre-filled Syringe

Treatment:

Biological: CT-P13 SC Pre-filled Syringe