Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 135134 | Other Identifier | IND |
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 compares two administration methods of CT-P13. Half of participants will receive CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.
This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 SC Auto-injector | Experimental | CT-P13 SC Auto-injector |
|
| CT-P13 SC Pre-filled Syringe | Experimental | CT-P13 SC Pre-filled Syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P13 SC Auto-injector | Biological | Each subject may receive single dose by subcutaneous administration using Auto-Injector |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects. | Pharmacokinetics will be assessed by AUC | over 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SuEun Song | Celltrion | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CT-P13 SC Pre-filled Syringe | Biological | Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe |
|