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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1331-0702 | Registry Identifier | ICTRP |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa.
The purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years.
Study details include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1 |
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| Treatment B | Experimental | Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab coformulated with berahyaluronidase alfa | Biological | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab | Cmax: Maximum concentration observed in serum | From Day 1 to Day 85 (end of study) |
| PK parameter in serum: AUClast of dupilumab | AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast | From Day 1 to Day 85 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs | From Day -1 to Day 85. | |
| Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | contact-us@sanofi.com |
| Name | Affiliation | Role |
|---|---|---|
| Angel Lamas, MD | Clinical Pharmacology of Miami (CPMI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami- Site Number : 8400001 | Recruiting | Hialeah | Florida | 33014 | United States |
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| Label | URL |
|---|---|
| PKM20425 Plain Language Results Summary | View source |
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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
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This study is open-label. Participants, investigators, and study members have access to treatment assignment.
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| Dupilumab | Biological | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection |
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| On Day 1, Day 43 and Day 85 |
| ID | Term |
|---|---|
| C582203 | dupilumab |
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