Safety and tolerability of GDC-0134 in ALS

Diagnosis ALS
Study phase Active
Participating centres UMC Utrecht

A phase 1, double-blind, randomized, placebo-controlled, multi-center, single- and multiple-ascending-dose study to determine initital safety, tolerability, and pharmacokinetics of GDC-0134 in patients with Amyotrophic Lateral Sclerosis (ALS).

This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and pharmacokinetic (PK) properties of GDC-0134. It will include three components: a Single-Ascending-Dose (SAD) stage, a Multiple-Ascending-Dose (MAD) stage, and an Open-Label Safety Expansion (OSE) stage.

Overall enrolment: 46-82 patients

Centers: 12 sites in the US, 1 site in Canada and 1 site in The Netherlands (UMCU)