A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
Running, not enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Frontotemporal Dementia
In brief
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.
Key facts
- Study ID
- NCT05262023
- Run by
- Denali Therapeutics Inc.
- People needed
- 85
- Starts
- 2022-02-01
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
Where it is running
- University of California San Francisco — San Francisco, California, United States
- John Hopkins University — Baltimore, Maryland, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Antwerp — Antwerp, Belgium
- UZ Leuven — Leuven, Belgium
- L2IP - Instituto de Pesquisas Clinicas LTDA — Brasília, Brazil
- Faculdade de Medicina Da Universidade de São Paulo — São Paulo, Brazil
- Hospital Universitario San Ignacio — Bogotá, Colombia
- Grupo de Neurosicencias de la Universidad de Antioquia — Medellín, Colombia
- Fakultni nemocnice v Motole — Prague, Czechia
- CHU de Nantes — Nantes, France
- CHU Rouen — Rouen, France
- CHU Toulouse — Toulouse, France
- ASST degli Spedali Civili di Brescia — Brescia, Italy
- Azienda Ospedaliera Universitaria Careggi — Florence, Italy
- IRCCS Istituto Auxologico Italiano — Milan, Italy
- Azienda Ospedaliera Cardinale G Panico — Tricase, Italy
- Erasmus University Medical Center — Rotterdam, Netherlands
- Hospital de Braga — Braga, Portugal
- Campus Neurológico Sénior — Torres Vedras, Portugal
- Hospital Clinic de Barcelona — Barcelona, Barcelona, Spain
- Hospital Universitario de Donostia — Donostia / San Sebastian, Guipúzcoa, Spain
- Hospital Universitario Virgen del Rocio — Seville, Sevilla, Spain
- Istanbul University Istanbul Medical Faculty — Istanbul, Turkey (Türkiye)
- Ondokuz Mayis University Hospital — Samsun, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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