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NCT05617183
Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects
Conditions: Healthy Subjects
Sex: All
Ages: 19 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 268
Sponsor: Celltrion
Location: Korea, Republic of
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.
Eligibility Criteria
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 significantClinically significant allergic reactions, hypersensitivityHistory or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilisActive or latent TuberculosisHistory of malignancyPrevious exposure to tocilizumab or any drug that targets IL-6
Source: ClinicalTrials.gov (NCT05617183). StuddyBuddy aggregates publicly available trial information.