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 64 人开始时间: 2024年4月8日最近更新: 2024年7月22日

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•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, both the male participant and his female partner must use highly effective contraception 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.

•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

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