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 groupsSponsors and collaborators
Source ClinicalTrials.gov