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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05188378
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Celltrion

Study Description
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Brief Summary:
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Condition or disease Intervention/treatment Phase
Healthy Subjects Biological: CT-P47 Biological: EU-approved RoActemra, Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : December 22, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : January 31, 2023
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Primary objective [ Time Frame: up to Day 43 ]
    To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)

  2. 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)

  3. Primary objective [ Time Frame: up to Day 43 ]
    To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05188378


Contacts
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Contact: YeonJu Kim 82-32-850-5774 yeonju.kim2@celltrion.com
Contact: KyungMin Park 82-32-850-5777 kyungmin.park@celltrion.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Kyungsang Yu    02-741-4221      
Principal Investigator: Kyungsang Yu         
Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: KyungSang Yu Seoul National University Hospital
Principal Investigator: JaeYong Chung Seoul National University Bundang Hospital
Principal Investigator: HyeWon Chung Korea University Guro 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
More Information
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT05188378    
Other Study ID Numbers: CT-P47 1.1
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No