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

NCT05188378 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-01-12

No results posted yet for this study

Summary

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

Conditions

  • Healthy Subjects

Interventions

BIOLOGICAL

CT-P47

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)

Sponsors & Collaborators

Principal Investigators

  • KyungSang Yu · Seoul National University Hospital

  • JaeYong Chung · Seoul National University Bundang Hospital

  • HyeWon Chung · Korea University Guro Hospital

  • DongSeong Shin · Gachon University Gil Medical Center

  • MinKyu Park · Chungbuk National University Hospital

  • MinGul Kim · Jeonbuk National University Hospital

  • JongLyul Ghim · Inje University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2022-10-01
Completion
2023-01-31

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188378 on ClinicalTrials.gov