Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-7002 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years.
The estimated duration is up to 21 days of screening period, followed by the treatment day with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total duration from screening to EOS will be 64 days maximum.
Duration per participant is up to 64 days
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New dupilumab product | Experimental | A single subcutaneous injection on Day 1 |
|
| Current dupilumab product | Active Comparator | A single subcutaneous injection on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab (SAR231893) | Drug | Injection solution Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration of functional dupilumab (Cmax) | Pre-dose on Day 1 up to Day 43 | |
| Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast) | Pre-dose on Day 1 up to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Day 1 up to Day 43 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami-Site Number:8400001 | Miami | Florida | 33014 | United States |
Not provided
| Label | URL |
|---|---|
| PKM17324 Plain Language Results Summary | View source |
Not provided
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided