A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Denali Therapeutics Inc.
With
Takeda
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
