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NCT05262023 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
A Phase 1 study of Frontotemporal Dementia, sponsored by Denali Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT05262023: Active Phase 1 study of Frontotemporal Dementia, sponsored by Denali Therapeutics.
NCT05262023 is a Phase 1 study of Frontotemporal Dementia that is active but no longer recruiting, run by Denali Therapeutics. The registered enrollment target is 85 participants, below the 1,194-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05262023, a Phase 1 study of Frontotemporal Dementia, is active but no longer recruiting, sponsored by Denali Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DNL593
Study Locations (20)
Other
- University of Antwerp - Antwerp
- UZ Leuven - Leuven
- L2IP - Instituto de Pesquisas Clinicas LTDA - Brasília
- Faculdade de Medicina Da Universidade de São Paulo - São Paulo
- Hospital Universitario San Ignacio - Bogotá
- Grupo de Neurosicencias de la Universidad de Antioquia - Medellín
- Fakultni nemocnice v Motole - Prague
- CHU de Nantes - Nantes
- CHU Rouen - Rouen
- CHU Toulouse - Toulouse
- ASST degli Spedali Civili di Brescia - Brescia
- Azienda Ospedaliera Universitaria Careggi - Florence
- IRCCS Istituto Auxologico Italiano - Milan
- Azienda Ospedaliera Cardinale G Panico - Tricase
- Erasmus University Medical Center - Rotterdam
- Hospital de Braga - Braga
- Campus Neurológico Sénior - Torres Vedras
California
- University of California San Francisco - San Francisco
Maryland
- John Hopkins University - Baltimore
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What the registry record for NCT05262023 still lists
NCT05262023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,194-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Frontotemporal Dementia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05262023 names 20 study sites across 4 states, led by Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT05262023 about?
NCT05262023 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)". This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will eval...
What is the current status of trial NCT05262023?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2022-02-01. Estimated completion is 2028-11.
What conditions does trial NCT05262023 study?
This clinical trial studies the following conditions: Frontotemporal Dementia.
What interventions are being tested in trial NCT05262023?
The interventions under investigation include: Placebo (DRUG), DNL593 (DRUG).
Who is sponsoring clinical trial NCT05262023?
This trial is sponsored by Denali Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05262023 being conducted?
This trial has 20 study locations across California, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05262023's enrollment target sits among peer trials
85 13th of 22 higher than 10 of 22 other Frontotemporal Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Frontotemporal Dementia 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.
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