A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) (NCT05262023)
A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label Extension
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco — San Francisco, California
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- University of California San Francisco — San Francisco, California
- John Hopkins University — Baltimore, Maryland
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- 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,
- Hospital Clinic de Barcelona — Barcelona, Barcelona
- Hospital Universitario de Donostia — Donostia / San Sebastian, Guipúzcoa
- Hospital Universitario Virgen del Rocio — Seville, Sevilla
- Istanbul University Istanbul Medical Faculty — Istanbul,
- Ondokuz Mayis University Hospital — Samsun,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Frontotemporal Dementia
- Neurofilament Surveillance Project (NSP) — San Francisco, California
- A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF72 Genes — Ann Arbor, Michigan
- Music, Social Attention, and Dementia — San Francisco, California
- Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) — Maitland, Florida
- Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia — Bethesda, Maryland
Explore by condition: All Frontotemporal Dementia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.