Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-07 @ 9:40 AM
Study NCT ID:
NCT05603195
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7508, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2024-09
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 REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.
This 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)
This 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-002001-20 | EUDRACT_NUMBER | None | View |