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

NCT06659640

Active Not RecruitingPhase 1, Phase 2

Sponsor: Alnylam Pharmaceuticals

Conditions: Hereditary Hemorrhagic Telangiectasia

Interventions: ALN-6400, Placebo

Countries: United States, Australia, Canada, France, Germany, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (16)
  • Birmingham, Alabama, United States
  • Cypress, California, United States
  • Gainesville, Florida, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Chapel Hill, North Carolina, United States
  • Camperdown, Australia
  • Parkville, Australia
  • Mount Royal, Canada
  • Toronto, Canada
  • Bordeaux, France
  • Bron, France
  • Homburg, Germany
  • L'Hospitalet de Llobregat, Spain