Status:
COMPLETED
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects
Lead Sponsor:
Celltrion
Conditions:
Healthy Subjects
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of ...
Detailed Description
CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio to receive a si...
Eligibility Criteria
Inclusion
- Healthy male subjects, between the ages of 18 and 55 years.
- Subject with a BMI between 18.5 and 29.9 kg/m2. Weight between 60 to 100 kg.
- Subject must agree to use medically acceptable methods of contraception consistent with local regulations during the course of the study and for 18 weeks after administration of the study drug.
- Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information.
Exclusion
- Subject has a prohibited medical history and/or current condition.
- Subject is planning to father a child or donate sperm within 18 weeks after the administration of the study drug (Day 1).
- Subject previously received any biologic agents
- In the opinion of the investigator, the subject is not eligible for the study participation for any reason.
- Subject is vulnerable.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2021
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT04428814
Start Date
August 3 2020
End Date
February 24 2021
Last Update
August 5 2021
Active Locations (2)
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1
Auckland Clinical Studies Limited
Grafton, Auckland, New Zealand, 1010
2
Christchurch Clinical Studies Trust Limited
Christchurch, Canterbury, New Zealand, 8011