Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515286-34-00 | EU Trial (CTIS) Number |
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 clinical research trial will evaluate the safety and tolerability of an experimental drug, ALN-F1202, in healthy participants.
The purpose of this trial is to learn about how safe and tolerable the experimental drug is. The trial is looking at several other research questions, including:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-F1202 | Experimental | Randomized as described in the protocol Escalating Cohorts including Optional Cohorts |
|
| Placebo | Experimental | Randomized as described in the protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-F1202 | Drug | Administered per the protocol |
| |
| Matching Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Up to 190 Days | |
| Severity of TEAEs | Up to 190 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in activated Partial Thromboplastin Time (aPTT) | Baseline up to 190 Days | |
| Change in Prothrombin Time (PT) | Baseline up to 190 Days | |
| Concentration of combined ALN-F1202 and metabolites in plasma |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven) | Leuven | Vlaams-Brabant | 3000 | Belgium |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered per the protocol |
|
| Up to 190 Days |
| Extent of urinary excretion of combined ALN-F1202 and metabolites | Within 24 hours of treatment |