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.

Age range19 Years – 55 Years

SexALL

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

✓. 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.

✕. 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

PK similarity demonstration by AUC

Timeframe: Day 43

PK similarity demonstration by Cmax

Timeframe: Day 43

NCT IDNCT05617183

SponsorCelltrion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04

MinAh Chun