NCT05188378

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

December 22, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 10, 2021

Last Update Submit

December 27, 2021

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

  • Primary objective

    To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)

    up to Day 43

  • 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 objective

    To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)

    up to Day 43

Study Arms (2)

CT-P47

EXPERIMENTAL

162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: CT-P47

EU-approved RoActemra

ACTIVE COMPARATOR

162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: EU-approved RoActemra,

Interventions

CT-P47BIOLOGICAL

162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

CT-P47
EU-approved RoActemra,BIOLOGICAL

162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

EU-approved RoActemra

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (1)

  • Yu KS, Kim B, Shin D, Park MK, Hwang JG, Kim MG, Chung H, Ghim J, Chung JY, Smolen JS, Burmester GR, Kim S, Bae Y, Jeon D, Yoo J, Yang G, Bae J, Keystone E. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study. Expert Opin Investig Drugs. 2023 May;32(5):429-439. doi: 10.1080/13543784.2023.2212155. Epub 2023 May 26.

    PMID: 37231670DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YeonJu Kim

CONTACT

82-32-850-5774yeonju.kim2@celltrion.com

KyungMin Park

CONTACT

82-32-850-5777kyungmin.park@celltrion.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 12, 2022

Study Start

December 22, 2021

Primary Completion

October 1, 2022

Study Completion

January 31, 2023

Last Updated

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)