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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: Completed Phase 1 study, sponsored by Denali Therapeutics.
NCT05006352 is a Phase 1 study that has completed, run by Denali Therapeutics. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT05006352 record still lists
NCT05006352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05006352 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05006352's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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