Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT06669234
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Safety and Tolerability Study of ALN-F1202 in Healthy Adults
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ALN-F1202, an siRNA Against Factor XII, in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2025-11
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 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:
* What side effects may happen from taking the experimental drug?
* How much experimental drug is in the blood at different times?
* Whether the body makes antibodies against the experimental drug (which could make the drug less effective or could lead to side effects).
* What is the best dose of the experimental drug?
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:
* What side effects may happen from taking the experimental drug?
* How much experimental drug is in the blood at different times?
* Whether the body makes antibodies against the experimental drug (which could make the drug less effective or could lead to side effects).
* What is the best dose of the experimental drug?
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 |
|---|---|---|---|---|
| 2024-515286-34-00 | CTIS | None | View |