Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05844293
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects
Sponsor:
Sirnaomics
Organization:
Study Overview
Official Title:
Single-center, Randomized, Double-blind, Placebo-controlled, Sequential Cohort Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAD of FXI-GalNAc-siRNA When Administered Subcutaneously to Healthy Subjects.
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The purpose of this study is to evaluate safety, tolerability, PK, and PD of SAD of FXI-GalNAc-siRNA administered SC to healthy subjects.
Detailed Description:
Phase 1, Single center, randomized, double-blind, sequential cohort study to evaluate safety, tolerability, PK and PD of a single ascending dose of FXI-GalNAc-siRNA when administered subcutaneously in healthy subjects compared with Normal Saline Injection.
The study will include a screening period, treatment period, and a follow-up period.
Five dose cohorts will be evaluated.
The study will include a screening period, treatment period, and a follow-up period.
Five dose cohorts will be evaluated.
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?:
None
Is an FDA AA801 Violation?: