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: Recruiting
Location: See all (8) 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
California
Clinical Trial Site
RECRUITING
Cypress
Massachusetts
Clinical Trial Site
RECRUITING
Boston
Other Locations
Canada
Clinical Trial Site
RECRUITING
Mount Royal
Clinical Trial Site
RECRUITING
Toronto
France
Clinical Trial Site
RECRUITING
Bordeaux
Clinical Trial Site
RECRUITING
Bron
Germany
Clinical Trial Site
RECRUITING
Homburg
Spain
Clinical Trial Site
RECRUITING
L'hospitalet De Llobregat
Contact Information
Primary
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2028-06-22
Participants
Target number of participants: 120
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