A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects

Launched by CELLTRION · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different ways of delivering a medication called CT-P43—a new treatment option. The researchers want to see how well the medication works, how safe it is, and how the body absorbs it when using an auto-injector versus a pre-filled syringe. This study is specifically targeting healthy males aged 19 to 55 years who weigh between 60 to 90 kg.

To participate, individuals must be in good health and not have any significant medical conditions or allergies. They also should not have a history of certain infections, like hepatitis or tuberculosis. If eligible, participants will receive either the auto-injector or pre-filled syringe of CT-P43 and will be monitored for safety and how their body responds to the medication. This trial is not yet recruiting, so interested individuals will need to wait for further announcements.

Gender

MALE

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 18.5 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 ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23