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

Phase 1

• Conditions: Healthy Subjects

• Registration Number: NCT05188378
• Lead Sponsor: Celltrion

Brief Summary

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

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 Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-10
• Study Start: 2021-12-22
• Study First Submitted QC: 2021-12-27
• Last Update Submitted: 2021-12-27
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12
• Primary Completion: 2022-10-01
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary objective	up to Day 43	To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of