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NCT05006352 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Denali Therapeutics.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT05006352 is a Phase 1 study that has completed, run by Denali Therapeutics. The registered enrollment target is 29 participants.

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The verdict

NCT05006352, a Phase 1 study, has completed, sponsored by Denali Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study 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)

Interventions

  • DRUG Placebo
  • DRUG DNL343

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2021-08-11
Est. Completion 2024-06-05
Phase Phase 1

Sponsor

Denali Therapeutics

12 total trials

What the Registry Record Tells You About NCT05006352

The ClinicalTrials.gov registry entry for NCT05006352 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denali Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05006352 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05006352 about?

NCT05006352 is a clinical study titled "A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis". 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)

What is the current status of trial NCT05006352?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2021-08-11. Estimated completion is 2024-06-05.

What interventions are being tested in trial NCT05006352?

The interventions under investigation include: Placebo (DRUG), DNL343 (DRUG).

Who is sponsoring clinical trial NCT05006352?

This trial is sponsored by Denali Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.