A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlnylam Pharmaceuticals
About this trial
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 criteria
Qualifiers
Is a healthy adult volunteer
Is an adult patient with a clinical diagnosis of HHT
Disqualifiers
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/1.73m² at screening
Has ALT or AST >2×ULN
Trial design
Treatments tested in this trial
- ALN-6400
- Placebo
Treatment groups
120 Participants
are divided into 4 treatment groupsLocations
16Australia
Clinical Trial Site2050, Camperdown Australia
Clinical Trial Site3050, Parkville Australia
Canada
Clinical Trial SiteH3P 3P1, Mount Royal Canada
Clinical Trial SiteM5B 1W8, Toronto Canada
Sponsors and collaborators
Alnylam Pharmaceuticals
Lead sponsor
Source ClinicalTrials.gov