ALN-HTT02-001
Recruiting
Official title: 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
Randomized, double-blind, placebo-controlled study. Looking at the safety, tolerability PK and PD of a new drug, ALN-HTT02 in adult HD patients.
The drug or placebo will be delivered by lumbar puncture(injected into the spine). It is a single injecton.
It will aim to lower both the normal(HTT) and mutant(mHTT) allele.
Phase: 1b
Subtype: Interventional Therapeutic
Primary Purpose: Treatment
Intervention Type: nucleic acid therapy
Primary Intervention: ALN-HTT02
Mode of Action: HTT Lowering, siRNA
Duration: 12 months
Ages Eligible
for Study:
25 Years to 70 Years (Adult, Older Adult )
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
No
- Has stage 2 or early Stage 3 Huntington’s disease (HD), per the Huntington’s Disease Integrated Staging System (HD-ISS)
- HD-ISS new staging for research
- Has significant structural or degenerative neurologic disease other than Huntington’s Disease (HD) at screening
- Has primary or secondary immune compromise at screening due to infections, medical conditions, or chronic therapies
- Has alanine aminotransferase or aspartate aminotransferase >2× upper limit of normal (ULN)
- Has an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m^2 at screening
- Has received an investigational agent within the last 1 year or 5 half-lives (if known)
LOCATIONS
COUNTRIES
Germany
TRIAL SITE: Bayern, Germany
Email: clinicaltrials@alnylam.com
TRIAL SITE: Berlin, Germany
Email: clinicaltrials@alnylam.com
TRIAL SITE: Bochum, Germany
Email: clinicaltrials@alnylam.com
TRIAL SITE: Bonn, Germany
Email: clinicaltrials@alnylam.com
TRIAL SITE: Dresden, Germany
Email: clinicaltrials@alnylam.com
TRIAL SITE: Ulm Germany
Email: clinicaltrials@alnylam.com
UK
TRIAL SITE: Birmingham, UK
Email: clinicaltrials@alnylam.com
TRIAL SITE: Cambridge, UK
Email: clinicaltrials@alnylam.com
TRIAL SITE: Cardiff, UK
Email: clinicaltrials@alnylam.com
TRIAL SITE: Glasgow, UK
Email: clinicaltrials@alnylam.com
TRIAL SITE: London, UK
Email: clinicaltrials@alnylam.com
TRIAL SITE: Manchester, UK
Email: clinicaltrials@alnylam.com
TRIAL SITE: Oxford, UK
Email: clinicaltrials@alnylam.com
TRIAL SITE: Plymouth, UK
Email: clinicaltrials@alnylam.com
