Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy Male Subjects.
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 single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a 1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1 and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all subjects will receive a study drug subcutaneously via PFS. The randomization to treatment assignment will be stratified by study center and body weight as measured at baseline to balance subject weight across treatment groups. Subjects will be confined to the study center until all required 24-hour post-dose assessments have been completed and will be discharged on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P43 (Part 1) | Experimental | 45mg single dose administration |
|
| EU-approved Stelara (Part 1) | Active Comparator | 45mg single dose administration |
|
| CT-P43 (Part 2) | Experimental | 45mg single dose administration |
|
| EU-approved Stelara (Part 2) | Active Comparator | 45mg single dose administration |
|
| US-licensed Stelara (Part 2) | Active Comparator | 45mg single dose administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P43 | Biological | 45mg single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate PK similarity | under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43, EU-approved Stelara, and US-licensed Stelara | through study completion, up to day 127 |
| Demonstrate PK similarity | maximum serum concentration (Cmax) of CT-P43, EU-approved Stelara, and US-licensed Stelara | through study completion, up to day 127 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland Clinical Studies Limited | Grafton | Auckland | 1010 | New Zealand | ||
| Christchurch Clinical Studies Trust Limited |
Not provided
Not provided
Not provided
Not provided
Not provided
| EU-approved Stelara |
| Biological |
45mg single dose |
|
| US-licensed Stelara | Biological | 45mg single dose |
|
| Christchurch |
| Canterbury |
| 8011 |
| New Zealand |