UnknownPhase 1

Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

South Korea268 participantsStarted 2022-11-15

Plain-language summary

This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.

Who can participate

Age range

19 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male or female subjects between the ages of 19 to 55 years, both inclusive.
. Subject with a 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PK similarity demonstration by AUC

Timeframe: Day 43

PK similarity demonstration by Cmax

Timeframe: Day 43

Trial details

NCT IDNCT05617183

SponsorCelltrion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04

Contact for this trial

MinAh Chun

+82 32 850 5761 minah.chun@celltrion.com

View on ClinicalTrials.gov More Healthy Subjects trials