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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Enrollment target: 87 to 85v17
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 106 to confirmed 87
    • Study sites: 32 to 26
    v16
  3. Study completion date: Dec 2026 to Nov 2028v15
  4. Primary and study completion dates: Nov 2025 to Dec 2026
    • Study sites: 29 to 32
    v14
  5. Site details revised at 14 of 29 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 28 to 29v12
  2. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 27 to 28
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 10 to 11
    v11
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 27 of 27 sites
    v10
  4. Study sites: 24 to 27v9
  5. Study sites: 13 to 24v8
  6. Study sites: 8 to 13v7
  7. Study sites: 5 to 8v6
  8. Site details revised at 5 of 5 sitesv5
  9. Study sites: 3 to 5v4
  10. Site contacts updated at 1 of 3 sitesv3
  11. Study sites: 1 to 3v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05262023
Lead Sponsor Denali Therapeutics Inc.
Collaborators: Takeda
Conditions
(from sponsor)		 Frontotemporal Dementia
Related terms Frontotemporal Dementia
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov