This is a first-in-human (FIH) study of RG6496 that will assess the safety and tolerability of single-ascending doses of RG6496 administered to huntington's disease gene expansion carriers (HDGECs). The study consists of two parts: Part 1 \[single-ascending dose\] followed by Part 2 \[open-label extension (OLE)\].
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1: Number of Participants With Adverse Events (AEs)
Timeframe: Up to approximately 24 months
Part 1: Change From Baseline in Neurological Assessment
Timeframe: Up to approximately 24 months
Part 1: Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Timeframe: Up to approximately 24 months
Part 1: Change from Baseline in Montreal Cognitive Assessment (MoCA)
Timeframe: Up to approximately 24 months
Part 2: Number of Participants With AEs
Timeframe: Up to approximately 38 months
Part 2: Change From Baseline in Neurological Assessment
Timeframe: Up to approximately 38 months
Part 2: Number of Participants With Suicidal Ideation or Behavior, as Assessed by C-SSRS Score
Timeframe: Up to approximately 38 months
Reference Study ID Number: BP45378 https://forpatients.roche.com/
Part 2: Change from Baseline in MoCA
Timeframe: Up to approximately 38 months