A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
NCT06659640 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-05-14
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
Conditions
- Hereditary Hemorrhagic Telangiectasia
Interventions
- DRUG
-
ALN-6400
ALN-6400 will be administered subcutaneously (SC)
- DRUG
-
Placebo will be administered subcutaneously (SC)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Alnylam Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-07
- Primary Completion
- 2028-01-05
- Completion
- 2028-06-22
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- France
- Germany
- Spain
Study Locations
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