A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, Followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis
Study Purpose:
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)
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
EnrollingPhase:
Phase IStudy Chair(s)/Principal Investigator(s):
Richard Tsai, MD Denali Therapeutics Inc.
Clinicaltrials.gov ID (11 digit #):
NCT05006352Neals Affiliated?
NoCoordinating Center Contact Information
Centre for Human Drug Research (CHDR)Project Manager / .(JavaScript must be enabled to view this email address) / +31 71 5246 400
.(JavaScript must be enabled to view this email address) Leiden, South Holland, Netherlands