RecruitingPhase 1Phase 2NCT06659640

A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

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)


Sponsor

Alnylam Pharmaceuticals

Enrollment

120 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ALN-6400 and a drug called Placebo for people with hereditary hemorrhagic telangiectasia. The study is currently recruiting participants at 16 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALN-6400

ALN-6400 will be administered subcutaneously (SC)

DRUGPlacebo

Placebo will be administered subcutaneously (SC)


Locations(16)

Clinical Trial Site

Birmingham, Alabama, United States

Clinical Trial Site

Cypress, California, United States

Clinical Trial Site

Gainesville, Florida, United States

Clinical Trial Site

Indianapolis, Indiana, United States

Clinical Trial Site

Boston, Massachusetts, United States

Clinical Trial Site

Rochester, Minnesota, United States

Clinical Trial Site

St Louis, Missouri, United States

Clinical Trial Site

Chapel Hill, North Carolina, United States

Clinical Trial Site

Camperdown, Australia

Clinical Trial Site

Parkville, Australia

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

View Full Details on ClinicalTrials.gov

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NCT06659640


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