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NCT05188378 Clinical Trial

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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05188378
Other study ID # CT-P47 1.1
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 22, 2021
Est. completion date January 31, 2023

Study information
Verified date December 2021
Source Celltrion
Contact YeonJu Kim
Phone 82-32-850-5774
Email yeonju.kim2@celltrion.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 31, 2023
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• CT-P47
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
• EU-approved RoActemra,
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary objective To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf) up to Day 43
Primary Primary objective 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 Primary objective To demonstrate PK similarity in terms of Maximum serum concentration (Cmax) up to Day 43
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