drugset / Trial / NCT07246941

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease

NCT07246941 ↗

Phase 1 Recruiting 40 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

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 \[open-label extension (OLE)\].

Timeline

Start
2025-11-19
Primary completion
2028-02-28
Completion
2029-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject RG6496 Unknown — Intrathecal

Indications