Clinical Trials Logo
  1. Home
  2. Health, Subjective
  3. NCT03446976
  4. Details
NCT03446976 Clinical Trial

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

Health, Subjective Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03446976
Other study ID # CT-P13 1.9
Secondary ID 135134
Status Completed
Phase Phase 1
First received
Last updated
Start date February 21, 2018
Est. completion date July 26, 2018

Study information
Verified date July 2019
Source Celltrion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 218
Est. completion date July 26, 2018
Est. primary completion date July 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• CT-P13 SC Auto-injector
Each subject may receive single dose by subcutaneous administration using Auto-Injector
• CT-P13 SC Pre-filled Syringe
Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe

Locations
Country Name City State
United States PPD Development, LP Austin Texas

Sponsors (1)
Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects. Pharmacokinetics will be assessed by AUC over 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT05533788 - ABSK091 Food Effect Study in Healthy Subjects Phase 1
Active, not recruiting NCT05541653 - The IGNITE Study on Concentrated Investment in Black Neighborhoods N/A
Active, not recruiting NCT04097119 - HDL Function Dietary Supplement Safety and QOL N/A
Not yet recruiting NCT03549403 - Effects of Patient-centered Telephone Education in Day Surgery N/A
Enrolling by invitation NCT05404386 - Effect of Mobile Application on Urinary Incontinence N/A
Completed NCT05366348 - The Effects of Horse-back Riding on Core Muscles in Adolescents N/A
Completed NCT04005456 - Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design N/A
Completed NCT04087525 - A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects Phase 1
Completed NCT05550610 - Evaluation of Mindfulness and Yoga in Basic Combat Training N/A
Completed NCT03311893 - Determine the Point of View of Society Society to Natural Orifice Surgeon N/A
Completed NCT04936373 - Quality of Life of Patients With Pregnancy Related VTE
Completed NCT03966625 - Serological Identification of Celiac Disease in Kids
Recruiting NCT05629351 - Prevalence of Sedentary Lifestyle, Pre-hypertension, and Obesity
Enrolling by invitation NCT03742128 - Health and Quality of Life Among Resettled Syrians in Norway
Completed NCT04648748 - Normative Data of Hand Grip Strength in Healthy Adult Pakistani Population
Completed NCT04616716 - A Food Effect Study of FMTN on Healthy Chinese Adult Subjects Phase 1
Recruiting NCT04766203 - Relative Energy Deficiency in Sport Multicenter Study N/A
Completed NCT03128671 - Family Automated Voice Reorientation Study N/A
Completed NCT05014958 - The Effect of Whole Body Vibration Training on Trunk Muscle Strength, Body Composition and Performance Parameters N/A
Completed NCT03828097 - The Effects of a Multi-vitamin Supplement in Adult Females N/A