A Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered Single Ascending Doses of ALN-HTT02 in Adult Patients With Huntington's Disease
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose of ALN-HTT02.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 70
Healthy Volunteers: f
View:
• Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS)
Locations
Other Locations
Canada
Clinical Trial Site
RECRUITING
Edmonton
Clinical Trial Site
RECRUITING
Montreal
Clinical Trial Site
RECRUITING
Ottowa
Clinical Trial Site
RECRUITING
Vancouver
Germany
Clinical Trial Site
RECRUITING
Bayern
Clinical Trial Site
RECRUITING
Berlin
Clinical Trial Site
RECRUITING
Bochum
Clinical Trial Site
RECRUITING
Bonn
Clinical Trial Site
RECRUITING
Dresden
Clinical Trial Site
RECRUITING
Ulm
Clinical Trial Site
RECRUITING
Venusberg
United Kingdom
Clinical Trial Site
RECRUITING
Birmingham
Clinical Trial Site
RECRUITING
Cambridge
Clinical Trial Site
RECRUITING
Cardiff
Clinical Trial Site
RECRUITING
Glasgow
Clinical Trial Site
RECRUITING
London
Clinical Trial Site
RECRUITING
Manchester
Clinical Trial Site
RECRUITING
Oxford
Clinical Trial Site
RECRUITING
Plymouth
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: 2024-10-14
Estimated Completion Date: 2028-07-05
Participants
Target number of participants: 54
Treatments
Experimental: ALN-HTT02
Participants will be administered a single dose of ALN-HTT02 during the Double-blind Part of the study. Participants who received ALN-HTT02 in the Double-blind part of the study will not receive an additional dose during the Open-label part of the study
Placebo_comparator: Placebo + ALN-HTT02
Participants will be administered a single dose of placebo during the Double-blind Part of the study. Participants will have the option to receive a single dose of ALN-HTT02 during the Open-Label Part of the study.
Related Therapeutic Areas
Sponsors
Leads: Alnylam Pharmaceuticals