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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03446976

Enrollment

218

Registered

2018-02-27

Start date

2018-02-21

Completion date

2018-07-26

Last updated

2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Subjective

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.

Interventions

BIOLOGICALCT-P13 SC Auto-injector

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

BIOLOGICALCT-P13 SC Pre-filled Syringe

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026