A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

December 27, 2021 updated by: Celltrion

A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects

A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Kyungsang Yu
        • Contact:
          • Kyungsang Yu
          • Phone Number: 02-741-4221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects
  • Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth

Exclusion Criteria:

  • A medical history and/or condition that is considered significant
  • Clinically significant allergic reactions, hypersensitivity
  • History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
  • Active or latent Tuberculosis
  • History of malignancy
  • Previous exposure to tocilizumab or any drug that targets IL-6

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-P47
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Biological: CT-P47
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Active Comparator: EU-approved RoActemra
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Biological: EU-approved RoActemra,
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary objective
Time Frame: up to Day 43
To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)
up to Day 43
Primary objective
Time Frame: up to Day 43
To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
up to Day 43
Primary objective
Time Frame: up to Day 43
To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)
up to Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Investigators

  • Principal Investigator: HyeWon Chung, Korea University Guro Hospital
  • Principal Investigator: KyungSang Yu, Seoul National University Hospital
  • Principal Investigator: JaeYong Chung, Seoul National University Bundang Hospital
  • Principal Investigator: DongSeong Shin, Gachon University Gil Medical Center
  • Principal Investigator: Minkyu Park, Chungbuk National University Hospital
  • Principal Investigator: Mingul Kim, Jeonbuk National University Hospital
  • Principal Investigator: JongLyul Ghim, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CT-P47 1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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