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

NCT05844293 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-18

No results posted yet for this study

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.

Conditions

  • FXI

Interventions

DRUG

FXI-GalNAc-siRNA

FXI-GalNAc-siRNA solution for injection

OTHER

Placebo

Saline

Sponsors & Collaborators

  • Sirnaomics

    lead INDUSTRY

Principal Investigators

  • Francois Lebel, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2024-05-31
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844293 on ClinicalTrials.gov