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Active, not recruiting Phase 1/2

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

NCT06659640 · tracked via the Priya Life Science France tracker
Phase
Phase 1/2
Started
2024-11-07
Last updated
2026-10-15

Condition(s) studied

Hereditary Hemorrhagic Telangiectasia

Investigational drug(s) / intervention(s)

ALN-6400 →Placebo

ALN-6400: ALN-6400 will be administered subcutaneously (SC)

Placebo: Placebo will be administered subcutaneously (SC)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria - Part A: * Is a healthy adult volunteer Part B: * Is an adult patient with a clinical diagnosis of HHT Exclusion Criteria - Part A: * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN) * Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection * Has an estimated glomerular filtration (eGFR) of \<90 mL/min/1.73m\^2 at screening Part B: * Has ALT or AST \>2×ULN * Has total bilirubin \>1.5×ULN * Has eGFR of \<30 mL/min/1.73m\^2 at screening Parts A and B: * Is not willing to comply with the contraceptive requirements during the study period Note: other protocol defined inclusion / exclusion criteria apply

Primary outcome measure(s)

  • Part A: Frequency of Adverse Events — Up to Week 36
  • Part B: Frequency of Adverse Events — Up to Week 96

Trial sites (16)

FacilityCityRegionStatus
Clinical Trial Site Birmingham Alabama
Clinical Trial Site Cypress California
Clinical Trial Site Gainesville Florida
Clinical Trial Site Indianapolis Indiana
Clinical Trial Site Boston Massachusetts
Clinical Trial Site Rochester Minnesota
Clinical Trial Site St Louis Missouri
Clinical Trial Site Chapel Hill North Carolina
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06659640 on ClinicalTrials.gov ↗ ← All trials in France