Actively Recruiting
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Led by Alnylam Pharmaceuticals · Updated on 2026-05-14
120
Participants Needed
16
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part A: Healthy adult volunteers
- Part B: Adult patients with a clinical diagnosis of Hereditary Hemorrhagic Telangiectasia (HHT)
You will not qualify if you...
- Part A: Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal (ULN)
- Part A: Known infection with HIV, or current or chronic hepatitis C or B virus
- Part A: Estimated glomerular filtration rate (eGFR) below 90 mL/min/1.73m² at screening
- Part B: ALT or AST levels greater than 2 times ULN
- Part B: Total bilirubin greater than 1.5 times ULN
- Part B: eGFR below 30 mL/min/1.73m² at screening
- Parts A and B: Unwillingness to comply with contraceptive requirements during the study period
- Other protocol defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 16 locations
1
Clinical Trial Site
Birmingham, Alabama, United States, 35233
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2
Clinical Trial Site
Cypress, California, United States, 90630
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3
Clinical Trial Site
Gainesville, Florida, United States, 32608
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4
Clinical Trial Site
Indianapolis, Indiana, United States, 46260
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5
Clinical Trial Site
Boston, Massachusetts, United States, 02114
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6
Clinical Trial Site
Rochester, Minnesota, United States, 55905
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7
Clinical Trial Site
St Louis, Missouri, United States, 63110
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8
Clinical Trial Site
Chapel Hill, North Carolina, United States, 27514
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9
Clinical Trial Site
Camperdown, Australia, 2050
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10
Clinical Trial Site
Parkville, Australia, 3050
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11
Clinical Trial Site
Mount Royal, Canada, H3P 3P1
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12
Clinical Trial Site
Toronto, Canada, M5B 1W8
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13
Clinical Trial Site
Bordeaux, France, 33000
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14
Clinical Trial Site
Bron, France, 69500
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15
Clinical Trial Site
Homburg, Germany, 66421
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16
Clinical Trial Site
L'Hospitalet de Llobregat, Spain, 8907
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Research Team
A
Alnylam Clinical Trial Information Line
CONTACT
A
Alnylam Clinical Trial Information Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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