A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects

Celltrion Healthcare

Status and phase

Not yet enrolling

Phase 1

Conditions

Healthy Male Subjects

Treatments

Biological: CT-P52

Study type

Interventional

Funder types

Industry

Identifiers

NCT07367958

CT-P52 1.2

Details and patient eligibility

About

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.

Full description

CT-P52, containing the active ingredient ixekizumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Taltz. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 will be evaluated in Healthy Male Subjects.

Enrollment

218 estimated patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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