NL-OMON56265招募中不适用
A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants with Amyotrophic Lateral Sclerosis - DNL343 in participants with ALS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Participants must satisfy all of the following criteria for study entry:
- •1. Women of non-childbearing potential and men, aged 18 to 80 years, inclusive
- •2. BMI of 18 to 35 kg/m2
- •3. Willing and able to give informed consent (via legally authorized
- •representative is acceptable) for study participation
- •4. Able to communicate with the investigator and staff
- •5. Willing and able to comply with the requirements of the study, including
- •scheduled visits, study restrictions, laboratory tests, and all other study
- •6. Women must have been surgically sterilized (hysterectomy, bilateral
- •oophorectomy, 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
- •follicle-stimulating hormone [FSH] level of > 40 IU/L at screening).
- •7. For men: When engaging in sex with a woman of childbearing potential
- •(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. See Section 10.6 of the protocol for
- •contraceptive guidance for female partners.
- •8. 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.
- •9. Diagnosis of laboratory-supported probable, probable, or definite (sporadic
- •or familial) ALS according to the El Escorial World Federation of Neurology
- •revised research diagnostic criteria (Ludolph et al. 2015)
- •10. Years since symptom onset as follows:
- •a. <= 3 years (approximately 80% or more of the study population)
- •b. > 3 to <= 4 years (limited to approximately <= 20% of the study population)
- •11. SVC > 50% predicted, measured within 28 days of screening (forced vital
- •capacity at screening also acceptable)
- •12. If participant is taking locally approved ALS treatments, the following
- •guidelines must be met:
- •a. If the participant is taking riluzole, doses must be stable for >= 42 days
- •prior to the first dose of study intervention; participant is expected to stay
- •on a stable regimen throughout the double-blind period of the study.
- •Participants who initiated or changed medication doses within 42 days prior to
- •the planned first dose of study intervention may be rescreened after dose
- •stabilization.
- •b. If the participant is taking any other locally approved ALS treatment
- •besides riluzole (e.g., edaravone), doses must be stable for >= 21 days prior
- •to the first dose of study intervention; the participant is expected to stay on
- •a stable regimen throughout the double-blind period of the study. For
- •edaravone, stable treatment regimen means completion of at least the first 14
- •days of treatment during the first treatment cycle with intent to continue
- •treatment cycles during the double-blind period. Participants who initiated or
- •changed medication doses within 21 days prior to the planned first dose of
- •study intervention may be rescreened after dose sta
排除标准
- •Participants who meet any of the following criteria will be excluded from study
- •1. 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
- •2. Positive serum pregnancy test or currently lactating or breastfeeding
- •3. History of malignancy within 5 years, except fully resected basal cell
- •carcinoma or other malignancies at low risk of recurrence, depending on
- •investigator and Medical Monitor agreement
- •4. History of clinically significant neurologic disorders other than ALS,
- •including stroke, significant cognitive impairment, or seizure within 5 years
- •of the first dose of study intervention, or head trauma with loss of
- •consciousness, documented by a physician, within 1 year of the first dose of
- •study intervention
- •5. History of serious adverse reaction or serious hypersensitivity to two or
- •more drug classes or clinically significant history of previous allergy or
- •hypersensitivity to DNL343 or any of the excipients contained within theDNL343
- •drug product
- •6. History of clinically significant hypersensitivity to local anesthetics that
- •may be used for LP (e.g., lidocaine)
- •7. Have criteria that would preclude an LP, such as a local infection at the
- •site of the LP, < 100 GI/L(100,000/mm3) platelets or clinically significant
- •coagulation abnormality or significant active bleeding, or treatment with an
- •anticoagulant or more than two antiplatelet agents
- •8. History of clinically significant back pathology and/or back injury (e.g.,
- •degenerative disease, spinal deformity, or spinal surgery) or severe
- •respiratory compromise that may predispose to complications or technical
- •difficulty with LP. Participants with ALS who cannot tolerate lumbar punctures
- •in the prone or lateral recumbent position due to respiratory difficulties may
- •undergo the procedure in an upright sitting position if the position resolves
- •respiratory distress.
- •9. Current significant psychiatric disorder, suicidal ideation in the previous
- •6 months as assessed by the Baseline/Screening version of the C-SSRS (a *yes*
- •response to question 1 or 2 on the Suicidal Ideation section may be acceptable
- •pending investigator and Sponsor Medical Monitor agreement and Intensity of
- •Ideation scores are 2 or lower), or a lifetime suicide attempt (a *yes*
- •response to question 4 or 5 on the Suicidal Ideation section or an Intensity of
- •Ideation score of 4 or 5) at screening. A lifetime suicide attempt or score of
- •4 or 5 on the Intensity of Ideation > 5 years may be allowed pending
- •investigator and Sponsor review.
- •10. History of alcoholism, drug abuse, or drug addiction in the previous 12
- •months Note: Participants who test positive for drugs included in the urine
- •drug screen (see Section 10.2) may be enrolled at the investigator*s discretion.
- •11. Evidence of hepatic impairment, including alanine aminotransferase (ALT) or
- •aspartate aminotransferase(AST) > 3 x the upper limit of normal (ULN) or
- •bilirubin > 1.5×ULN at screening or baseline. Patients with Gilbert*s syndrome
- •without evidence of hepatic impairment may be enrolled.
- •12. History of clinically significant renal impairment o
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