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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-08-11 |
| Est. Completion | 2024-06-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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.
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