A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT) (NCT06659640)
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)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).
Location: Clinical Trial Site — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (16 Sites)
- 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,
- Clinical Trial Site — Parkville,
- Clinical Trial Site — Mount Royal,
- Clinical Trial Site — Toronto,
- Clinical Trial Site — Bordeaux,
- Clinical Trial Site — Bron,
- Clinical Trial Site — Homburg,
- Clinical Trial Site — L'Hospitalet de Llobregat,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hereditary Hemorrhagic Telangiectasia
- DIAG723 in Adults With Hereditary Hemorrhagic Telangiectasia — Camperdown, New South Wales
- CHORUS - Comprehensive HHT Outcomes Registry of the United States (Formerly OUR HHT Registry) — Toronto, Ontario
- Comprehensive HHT Outcomes Registry of the United States (CHORUS) — Birmingham, Alabama
- Bevacizumab In Hereditary Hemorrhagic Telangiectasia — Boston, Massachusetts
- Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz) — Los Angeles, California
Explore by condition: All Hereditary Hemorrhagic Telangiectasia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.