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RECRUITING
NCT06659640
PHASE1/PHASE2

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

Sponsor: Alnylam Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

ALN-6400

ALN-6400 will be administered subcutaneously (SC)

DRUG

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