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Clinical Trials in Turkey / NCT05262023
Active, not recruiting Phase 1/2

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

NCT05262023 · tracked via the Priya Life Science Turkey tracker
Sponsor
Denali Therapeutics Inc
Phase
Phase 1/2
Started
2022-02-01
Last updated
2026-01-15

Condition(s) studied

Frontotemporal Dementia

Investigational drug(s) / intervention(s)

DNL593Placebo

DNL593: Ascending single doses (for healthy participants) and multiple doses (for participants with FTD)

Placebo: Ascending single doses (for healthy participants) and multiple doses (for participants with FTD)

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Key Inclusion Criteria: Part A: * Women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 55 years * BMI of ≥ 18 to ≤ 32 kg/m² * When engaging in sex with a woman of child bearing potential, two forms of birth control are required Part B: * Women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 80 years. Women who are of childbearing potential but on highly effective, low user dependent contraceptive methods will be allowed. * BMI of ≥ 18 to ≤ 32 kg/m² * Have a Clinical Dementia Rating® plus National Alzheimer's Coordinating Center frontotemporal lobar degeneration global score ≥ 0.5 * Have confirmed granulin (GRN) mutation via genetic testing or historical records available for review by investigator * When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception Part C: * All participants who completed Part B of this trial are eligible for an 18-month OLE if the participant has no unresolved clinically significant TEAEs, where continued dosing may represent a risk to participant safety. Key Exclusion Criteria: * Have any history of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders * Have a history of malignancy, except fully resected basal cell carcinoma or other malignancies at low risk of recurrence * Have a clinically significant history of stroke, cognitive impairment due to causes other than FTD, seizure within 5 years of screening, or head trauma with loss of consciousness within 2 years of screening * Have a positive serum pregnancy test or are currently lactating or breastfeeding

Primary outcome measure(s)

  • Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) — up to 18 months
  • Incidence of treatment-emergent clinically significant abnormalities in safety laboratory values — up to 18 months
  • Change from baseline in vital sign measurements: systolic and diastolic blood pressure — up to 18 months
  • Change from baseline in vital sign measurements: heart rate — up to 18 months
  • Change from baseline in vital sign measurements: respiratory rate — up to 18 months
  • Change from baseline in vital sign measurements: body temperature — up to 18 months
  • Change from baseline in electrocardiogram (ECG) results including PR, QRS, and QTcF intervals — up to 18 months
  • Incidence of treatment-emergent clinically significant abnormalities in physical/neurological examination findings — up to 18 months
  • Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS; Parts B and C only) — up to 18 months

Trial sites (26)

FacilityCityRegionStatus
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 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
Hospital Universitario de Donostia Donostia / San Sebastian Guipúzcoa
Hospital Universitario Virgen del Rocio Seville Sevilla
Istanbul University Istanbul Medical Faculty Istanbul Turkey (Türkiye)
Ondokuz Mayis University Hospital Samsun Turkey (Türkiye)
Simbec Orion Merthyr Tydfil Wales

More Denali Therapeutics Inc. trials in Turkey

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II) Active, not recruiting
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007 Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05262023 on ClinicalTrials.gov ↗ ← All trials in Turkey