Status:
ACTIVE_NOT_RECRUITING
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects
Lead Sponsor:
Celltrion
Conditions:
Healthy Male Subjects
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 in Healthy Male Subjects.
Detailed Description
CT-P43, containing the active ingredient ustekinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Stelara. In this study, Pharmacokinetics, Safety and Immu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06951828
Start Date
May 30 2025
End Date
April 1 2026
Last Update
September 9 2025
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, Guro-gu, South Korea, 08308