CompletedInterventionalPhase 1Last updated Sep 19, 2024

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

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

Overview

ClinicalTrials.gov ID: NCT05006352
Lead Sponsor: Denali Therapeutics Inc.INDUSTRY
Brief 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)
Study Type

Status

Overall Status: Completed
Start Date: Aug 11, 2021Actual
Primary Completion Date: Dec 15, 2022Actual
Completion Date: Jun 5, 2024Actual

Study Record Dates

First Submitted: Aug 7, 2021
First Submitted that Met QC Criteria: Aug 13, 2021
First Posted: Aug 16, 2021Actual
Last Update Submitted that Met QC Criteria: Sep 12, 2024
Last Update Posted: Sep 19, 2024Actual
Last Verified: Sep 2024

NCT03757351Terminated

Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis

NCT04268784Completed

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers

NCT04557800Completed

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

NCT03710707Completed

Study to Evaluate DNL201 in Subjects With Parkinson's Disease

NCT07758595Not yet recruiting

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease

NCT07328451Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease