InsigHHT: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-6400 in Adult Healthy Volunteers and Multiple Dose ALN-6400 in Adult Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Status: Active_not_recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
⁃ Part A:
• Is a healthy adult volunteer
⁃ Part B:
• Is an adult patient with a clinical diagnosis of HHT
Locations
United States
Alabama
Clinical Trial Site
Birmingham
California
Clinical Trial Site
Cypress
Florida
Clinical Trial Site
Gainesville
Indiana
Clinical Trial Site
Indianapolis
Massachusetts
Clinical Trial Site
Boston
Minnesota
Clinical Trial Site
Rochester
Missouri
Clinical Trial Site
St Louis
North Carolina
Clinical Trial Site
Chapel Hill
Other Locations
Australia
Clinical Trial Site
Camperdown
Clinical Trial Site
Parkville
Canada
Clinical Trial Site
Mount Royal
Clinical Trial Site
Toronto
France
Clinical Trial Site
Bordeaux
Clinical Trial Site
Bron
Germany
Clinical Trial Site
Homburg
Spain
Clinical Trial Site
L'hospitalet De Llobregat
Time Frame
Start Date: 2024-11-07
Completion Date: 2028-06-22
Participants
Target number of participants: 89
Treatments
Experimental: Part A: ALN-6400
Participants will be administered a single dose of ALN-6400.
Placebo_comparator: Part A: Placebo
Participants will be administered a single dose of placebo.
Experimental: Part B: ALN-6400
Participants will be administered multiple doses of ALN-6400.
Placebo_comparator: Part B: Placebo
Participants will be administered multiple doses of placebo.
Related Therapeutic Areas
Sponsors
Leads: Alnylam Pharmaceuticals