NCT05844293

Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sirnaomics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• FXI

Interventions

Type	Name	Description
DRUG	FXI-GalNAc-siRNA	FXI-GalNAc-siRNA solution for injection
OTHER	Placebo	Saline

Timeline

• Start date: 2023-05-16
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2023-05-06
• Last updated: 2024-03-18

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study