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 - DNLI-H-0001

Denali Therapeutics Inc.0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月9日

研究概览

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•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
•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.

•Have any history of clinically significant neurologic, psychiatric,
•endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic,
•renal, metabolic, hematologic, immunologic, or allergic disease, or other major
•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

发起方