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 (2) 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
Maximum Age: 65
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
Other Locations
Canada
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Montreal
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: 2024-11-11
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