Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237309
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-01-23
Brief Title:
A Trial to Learn How REGN5381 Works and How Safe it is in Adults With Heart Failure With Reduced Ejection Fraction HFrEF
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of a Single Dose of REGN5381 an NPR1 Monoclonal Antibody Agonist in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an experimental drug called REGN5381 called study drug The study is focused on patients with heart failure with reduced ejection fraction ie the heart is not functioning as well as it should
The aim of the study is to see how safe tolerable and effective the study drug is
The study is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
The aim of the study is to see how safe tolerable and effective the study drug is
The study is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508568-31-00 | REGISTRY | EU CTR Number | None |