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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001794-23 | EudraCT Number |
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The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Pozelimab: Single-dose SC on day 1 |
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| Cohort 2 | Experimental | Pozelimab: Single-dose IV on day 1 |
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| Cohort 3 | Experimental | Pozelimab: Single-dose SC on day 29 Cemdisiran: Single-dose SC on day 1 |
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| Cohort 4 | Experimental | Pozelimab: Single-dose SC on day 1 Cemdisiran: Single-dose SC on day 1 |
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| Cohort 5 | Experimental | Optional Pozelimab: Single-dose SC on day 1 or day 29 Cemdisiran: Single-dose SC on day 1 |
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| Cohort 6 | Experimental | Pozelimab: Single-dose IV on day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pozelimab | Drug | Administered intravenous (IV) or subcutaneous (SC) per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of pozelimab in serum over time | Up to 20 weeks | |
| Concentrations of cemdisiran in plasma over time. | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of treatment-emergent adverse events (TEAE) in subjects administered pozelimab with/without cemdisiran | Up to 20 weeks | |
| Concentrations of total C5 in plasma over time | Up to 20 weeks |
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Key Inclusion Criteria:
Japanese participant must be:
Has a Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) at screening visit
Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECGs performed at screening and/or prior to administration of initial dose of study drug
Is in good health based on laboratory safety testing obtained at the screening visit Note: Participant with suspected or confirmed Gilbert's disease can be enrolled in the study
Willing to undergo vaccination against N. meningitidis unless participant has documentation of completed series of vaccinations within the past 2 years of the screening visit
Must have two consecutive negative COVID-19 tests at least 48 hours apart and within 7 days prior to study drug administration Note: The test may be the point of care quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) test or approved COVID-19 antigen test at the discretion of the investigator.
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion and Exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | London | SE1 1YR | United Kingdom |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Cemdisiran | Drug | Administered SC per protocol |
|
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| Change from baseline in CH50 over time | Up to 20 weeks |
| Incidence of treatment-emergent anti-drug antibodies (ADA) to pozelimab | Up to 20 weeks |
| Incidence of treatment-emergent ADA to cemdisiran | Up to 20 weeks |