drugset / Trial / NCT05006352

A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

NCT05006352

Phase 1 Completed 29 enrolled Denali Therapeutics Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL343 in participants with amyotrophic lateral sclerosis (ALS)

Timeline

Start
2021-08-11
Primary completion
2022-12-15
Completion
2024-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject EVETIFATOR Small molecule Oral