EUCTR2021-005733-16-IT招募中1 期
A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double-BlindSingle Dose and Multiple Dose Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Pharmacodynamics of DNL593 in HealthyParticipants and Participants With Frontotemporal Dementia Followed byan Open-Label Extension - Part B, C of first in human study of DNL593 in healthy volunteers & FTD patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Aged = 18 to = 80 years
- •2.Have a BMI of = 18 to = 32 kg/m2
- •3.Are willing and able to give informed consent for study participation or
- •have a care partner or LAR who is willing and
- •able to provide consent
- •4.Have a study partner who is able to reliably complete the CDR plus
- •NACC FTLD with participant and will accompany
- •the participant to study visits or be available by telephone at designated
- •XML File Identifier: X1p9IGlxXhTZyCsn88i37S2AvA8=
- •times. Study partner must have frequent
- •contact with participant (> 10 hours per week) and be able to
- •reasonably participate in all CDR plus NACC FTLD
- •assessments in the study period.
- •Note: A second study partner may serve as backup, but it is preferred
- •that one study partner be primarily responsible
- •for the CDR plus NACC FTLD assessments.
- •5.Are able to communicate with the investigator and staff either
- •independently or through a caregiver
- •6.Are willing and able to comply with the requirements of the study,
- •including scheduled visits, study restrictions,
- •laboratory tests, and all other study procedures. In the investigator's
- •opinion, both participant and caregiver are able to
- •complete all required study procedures and visits during the Part B
- •period of 24 weeks.
- •7.Women of non-childbearing potential, defined as must have been
- •surgically sterilized (hysterectomy, bilateral
- •oophorectomy/salpingectomy, or bilateral tubal ligation; proper
- •documentation required) > 3 months prior to dosing
- •(Essure fallopian tube coil placement is not accepted as surgical
- •sterilization because of the high failure rate), or be
- •postmenopausal (amenorrheic for > 12 consecutive months before
- •dosing, with a FSH level of > 40 IU/L at screening).
- •Women who are of childbearing potential but on highly effective, low
- •user dependent contraceptive methods will be
- •8.For men: When engaging in sex with a WOCBP, both the male
- •participant and his female partner must use highly
- •effective contraception consisting of two forms of birth control, one of
- •which must be a male barrier method (such as a
- •latex or polyurethane condom), from the start of dosing, throughout the
- •study period, and for 90 days after the final
- •administration of study intervention.
- •9.For men: The participant must not donate sperm at any time from the
- •start of dosing, throughout the study period,
- •and for 90 days after the final administration of study intervention.
- •10.Have a diagnosis of FTD, including the probable bvFTD or PPA. Other
- •diagnosis related to FTD syndrome,
- •including, but not limited to, CBS or progressive supranuclear palsy
- •(PSP) syndrome, are allowed pending Sponsor
- •and investigator agreement.
- •11.Have a CDR plus NACC FTLD global score = 0.5
- 另有 15 项未显示
排除标准
- •1.Have any history of unstable or poorly controlled psychiatric,
- •endocrine, pulmonary, cardiovascular, gastrointestinal,
- •hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or
- •allergic disease, or other major disorders. Well
- •controlled conditions are permitted if investigator and Sponsor agree.
- •2.Have a history of malignancy within 5 years before screening, except
- •fully resected basal cell carcinoma or other
- •malignancies (such as prostate cancer) at low risk of recurrence,
- •depending on investigator and medical monitor
- •3.Have a history of clinically significant neurologic disorders other than
- •FTD (for Part B only), including stroke, cognitive
- •impairment due to causes other than FTD, or seizure within 5 years of
- •screening, or head trauma with loss of
- •consciousness within 2 years of screening. Note: Single incidence of
- •provoked seizure with a clear cause may be
- •acceptable with Investigator and Sponsor approval.
- •4.Have the presence of any contraindication to MRI of the brain
- •5.Have a current significant psychiatric disorder, suicidal ideation in the
- •previous 6 months as assessed by the
- •Baseline/Screening version of the C-SSRS (for Part B only)
- •6.Have evidence of hepatic impairment, including ALT or AST > 2 × ULN
- •or bilirubin> 1.5 × ULN at screening or
- •7.Have a history of clinically significant renal impairment or an eGFR <
- •45 mL/min/1.73 m2 at screening
- •8.Have a history or presence of a clinically significant ECG abnormality
- •9.Have donated or lost > 500 mL whole blood within 30 days before
- •entry in the treatment period
- •10.Received vaccination (including second dose or any booster shots)
- •against SARS-CoV-2 within 4 weeks of the start
- •11.Have any other issue that, in the opinion of the investigator, would
- •make the participant ineligible for study
- •participation
- •For full exclusion criterion for Part B, please refer to Section 5.1.2.2 of
- •the protocol.6.10.
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