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 - Part B, C of first in human study of DNL593 in healthy volunteers & FTD patients

Denali Therapeutics Inc.0 个研究点目标入组 40 人开始时间: 2022年6月22日最近更新: 2024年4月15日

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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 118-month OLE if the participant has no unresolved clinically significant TEAEs, where continued dosing may represent a risk to participant safety.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 11
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 17

•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
•For full exclusion criterion for Part B, please refer to Section 5.1.2.2 of the protocol.

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