Status:
RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
Lead Sponsor:
Denali Therapeutics Inc.
Collaborating Sponsors:
Takeda
Conditions:
Frontotemporal Dementia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05262023
Start Date
February 1 2022
End Date
November 1 2028
Last Update
September 15 2025
Active Locations (32)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
John Hopkins University
Baltimore, Maryland, United States, 21218
3
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
University of Antwerp
Antwerp, Belgium