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Completed
NCT07367958
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects
Conditions: Healthy Male Subjects
Sex: Male
Ages: 19 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 218
Sponsor: Celltrion
Location: Korea University Guro Hospital Seoul Seoul (Seoul Special City)
Summary
This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 in Healthy Male Subjects.
Eligibility Criteria
Inclusion Criteria:
* Healthy male subjects, between the ages of 19 and 55 years, both inclusive.
* Subject has a body weight between 60 to 90 kg, both inclusive, and a BMI between 18.0 and 29.9 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 ixekizumab or a biosimilar of ixekizumab or any drug that directly targets Interleukin (IL)-17 or the IL-17 receptor
Source: ClinicalTrials.gov (NCT07367958). StuddyBuddy aggregates publicly available trial information.
