NL-OMON50153已完成不适用
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL002 in Healthy Participants and in Participants with Mild to Moderate Alzheimer*s Disease. - AL002-1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Alector Inc.
- 入组人数
- 10
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
- •1. Total body weight between 50 and 120 kg, inclusive.
- •2. Clinical laboratory evaluations (including chemistry panel fasted [fasted at
- •least 8 hours], complete blood count, and urine analysis) within the reference
- •range for the test laboratory, unless deemed not clinically significant by the
- •Investigator. A count of the segmented neutrophils and bands should be
- •performed when results from the white blood cells (WBCs) are not within the
- •reference range.
- •3. Negative test for selected drugs of abuse at screening (does not include
- •alcohol) and at admission (testing at admission does include alcohol breath
- •test). A positive result may be verified by re-testing (up to 1 false positive
- •result permitted) and may be followed up at the discretion of the Investigator.
- •4. Females must be non-pregnant and non-lactating, and either surgically
- •sterile (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral
- •oophorectomy), or use highly effective contraceptive method (oral
- •contraceptives pills [OCPs], long acting implantable hormones, injectable
- •hormones, a vaginal ring or an intrauterine device [IUD]) from screening until
- •study completion, including the follow-up period for at least 16 weeks after
- •the last dose of AL002, or be post-menopausal for *12 months. For healthy
- •volunteers, post-menopausal status will be confirmed through testing of FSH
- •levels (* 40 IU/mL) at screening; for participants with AD, post-menopausal
- •status will be assessed through medical history with assessment of potential
- •alternative causes of amenorrhea as clinically indicated). Females who are
- •abstinent from heterosexual intercourse will also be eligible.
- •5. Women of child-bearing potential (WOCBP) must have a negative pregnancy test
- •at screening and admission and be willing to have additional pregnancy tests as
- •required throughout the study.
- •6. Males must be surgically sterile (>30 days since vasectomy with no viable
- •sperm), abstinent, or if engaged in sexual relations with a WOCBP, the
- •participant and his partner must be surgically sterile (e.g. tubal occlusion,
- •hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an
- •acceptable, highly effective contraceptive method from screening until study
- •completion, including the follow-up period, for at least 16 weeks after the
- •last dose of AL002. Acceptable methods of contraception include the use of
- •condoms and the use of an effective contraceptive for the female partner
- •(WOCBP) that includes: OCPs, long acting implantable hormones, injectable
- •hormones, a vaginal ring or an IUD. Male participants whose female partner is
- •post-menopausal, and participants who are abstinent from heterosexual
- •intercourse will also be eligible. Male participants must agree to refrain from
- •donating sperm from screening until study completion, including the follow-up
- •period, for at least 16 weeks after the last dose of AL002.
- •In addition, for the MD cohorts (i.e. participants with AD):
- •9. Ages 50-85 years, inclusive.
- •10. The participant should be capable of completing assessments either alone or
- •with the help of the study partner (where appropriate), per local guidelines.
- •11. Availability of a person (*study partner*) who, in the Investigator's
- •judgment, has frequent and sufficient contact with the participant and is able
- •to provide accurate inf
排除标准
- •1. Pregnant, lactating, or intending to become pregnant within 16 weeks after
- •last dose of study drug.
- •2. Participation in a clinical trial within 30 days before randomization; use
- •of any experimental oral therapy within 30 days or 5 half-lives prior to Day 1,
- •whichever is greater; or use of any biologic therapy within 12 weeks or 5
- •half-lives prior to Day 1, whichever is greater. Participants who have received
- •an experimental therapy that has no half-life, like a vaccine, should have
- •completed that therapy at least 12 weeks prior to Day 1. Participants who have
- •received an experimental vaccine against a central nervous system target, such
- •as beta-amyloid or tau, are not eligible for this study.
- •3. Any non-experimental vaccine within 2 weeks of randomization, until 2 weeks
- •after the last dose. It is advised that prospective participants receive their
- •annual influenza vaccine as early as possible in advance of the flu season, and
- •then wait 2 weeks prior to randomization. It is permitted to receive the annual
- •influenza vaccine during the screening period.
- •4. Surgery or hospitalization during the 4 weeks prior to screening.
- •5. Planned procedure or surgery during the study.
- •6. Blood transfusion within 8 weeks prior to screening.
- •7. Donation or loss of blood (excluding the volume of blood that will be drawn
- •during screening procedures) as follows: 50-499 mL of blood within 30 days or >
- •499 mL of blood within 56 days prior to study drug administration.
- •8. Poor peripheral venous access.
- •9. History of major depression (within the past 5 years) unless effectively
- •treated at enrollment and for the duration of the study, at the discretion of
- •the Investigator. History of schizophrenia, schizoaffective disorder, or
- •bipolar disorder.
- •10. Alcohol and/or substance abuse or dependence (according to the Diagnostic
- •and Statistical Manual of Mental Disorders, Fifth Edition) within the past 2
- •11. Within the last 2 years, unstable or clinically significant cardiovascular
- •disease (e.g. myocardial infarction, angina pectoris, New York Heart
- •Association Class II or more cardiac failure).
- •12. Uncontrolled abnormal blood pressure
- •a. For healthy volunteers, as indicated by sustained supine systolic blood
- •pressure (BP) > 140 or < 90 mm Hg or supine diastolic blood pressure > 90 or
- •<50 mm Hg at screening or admission. Duplicate assessments will be performed
- •and the average of the 2 assessments of BP will be used to exclude a
- •participant.
- •b. For MD participants with AD, sustained diastolic blood pressure >95 mm Hg
- •performed either sitting or supine. No repeated measurements for eligibility
- •are required for multidose participants.
- •13. Resting heart rate at screening of >100 or < 40 beats per minute.
- •14. Chronic kidney disease as indicated by a screening creatinine clearance <
- •30 mL/min as calculated by the central laboratory using the Cockcroft Gault
- •formula, which remains < 30 mL/min if retested.
- •15. Impaired hepatic function as indicated by screening aspartate
- •aminotransferase (AST) or alanine aminotransferase (ALT) * 2 or total bilirubin
- •* 1.5 x the upper limit of normal, which remains above these limits if retested
- •due to a slightly elevated initial result or abnormalities in synthetic
- •function tests that are judged by the Investigator to be clinically significant.
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