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A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease

RecruitingPhase 1

Sponsor: Alnylam Pharmaceuticals

Conditions: Huntington's Disease

Interventions: ALN-HTT02, Placebo

Countries: Canada, Germany, United Kingdom

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.

Eligibility overview

Sex: ALL

Age: 25 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS)

Exclusion Criteria

* 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 \<60 mL/min/1.73m\^2 at screening
* Has received an investigational agent within the last 1 year or 5 half-lives (if known)

Note: other protocol defined inclusion / exclusion criteria apply

Locations (19)

Edmonton, Canada
Montreal, Canada
Ottawa, Canada
Vancouver, Canada
Berlin, Germany
Bochum, Germany
Bonn, Germany
Dresden, Germany
Münster, Germany
Taufkirchen, Germany
Ulm, Germany
Birmingham, United Kingdom
Cambridge, United Kingdom
Cardiff, United Kingdom
Glasgow, United Kingdom
Greater Manchester, United Kingdom
London, United Kingdom
Oxford, United Kingdom
Plymouth, United Kingdom