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
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Subjects

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