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

Sponsor

Celltrion (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05188378

Collaborator

(none)

300

Enrollment

Location

Arms

13.3

Anticipated Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Dec 22, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

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)

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

Primary Outcome Measures

Primary objective [up to Day 43]
To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)
Primary objective [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)
Primary objective [up to Day 43]
To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Celltrion

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celltrion

ClinicalTrials.gov Identifier:

NCT05188378

Other Study ID Numbers:

CT-P47 1.1

First Posted:

Jan 12, 2022

Last Update Posted:

Jan 12, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 12, 2022