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Recruiting
NCT06659640
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Conditions: Hereditary Hemorrhagic Telangiectasia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 120
Sponsor: Alnylam Pharmaceuticals
Location: Clinical Trial Site Birmingham Alabama
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 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 \2×ULN
* Has total bilirubin \>1.5×ULN
* Has eGFR of \
Source: ClinicalTrials.gov (NCT06659640). StuddyBuddy aggregates publicly available trial information.