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A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Sponsor: Alnylam Pharmaceuticals
Summary
The purpose of this study is to: * evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers * evaluate the efficacy, safety, tolerability and PD of multiple doses of ALN-6400 in adult patients with HHT
Official title: InsigHHT: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-6400 in Adult Healthy Volunteers and Multiple Dose ALN-6400 in Adult Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-11-07
Completion Date
2028-06-22
Last Updated
2026-04-03
Healthy Volunteers
Yes
Conditions
Interventions
ALN-6400
ALN-6400 will be administered subcutaneously (SC)
Placebo
Placebo will be administered subcutaneously (SC)
Locations (8)
Clinical Trial Site
Cypress, California, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Mount Royal, Canada
Clinical Trial Site
Toronto, Canada
Clinical Trial Site
Bordeaux, France
Clinical Trial Site
Bron, France
Clinical Trial Site
Homburg, Germany
Clinical Trial Site
L'Hospitalet de Llobregat, Spain