ACTRN12621000514808已完成1 期
A Phase 1, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy ofmEphA4-Fc in Healthy Volunteers and Patients with Amyotrophic Lateral Sclerosis (ALS)
uNerve Pty. Ltd.0 个研究点目标入组 28 人开始时间: 2021年5月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Healthy Volunteers:
- •1. Healthy male or female volunteers aged 18 to 55 years of age (inclusive at the time
- •of informed consent).
- •2. Subjects must be in good general health, with no significant medical history, have
- •no clinically significant abnormalities on physical examination at Screening and/or
- •before administration of the initial dose of study drug.
- •3. Subjects must have a minimum body weight of 50 kg and a Body Mass Index
- •(BMI) between greater than or equal to 18.0 and lesser than or equal to 32.0 kg/m2 at Screening.
- •4. Subjects must have clinical laboratory values within normal range as specified by
- •the testing laboratory, unless deemed not clinically significant by the Investigator
- •or delegate.
- •5. Subjects who smoke no more than 2 cigarettes or equivalent per week can be
- •included in the study but must be willing to abstain from smoking during the
- •confinement period.
- •ALS Patients;
- •1. Males and females aged 18 to 70 years of age (inclusive at the time of informed consent).
- •2. Must have a minimum body weight of 50 kg and a BMI between greater than or equal to 18.0 and less than or equal to 32.0 kg/m2 at Screening.
- •3. Patients who smoke no more than 2 cigarettes or equivalent per week can be
- •included in the study but must be willing to abstain from smoking during the
- •confinement period.
- •4. Patients with diagnosis of familial or sporadic ALS, defined as meeting the
- •possible, laboratory-supported probable, probable, or definite diagnosis of ALS
- •according to modified El Escorial criteria.
- •5. Onset of muscle weakness within 60 months of study entry.
排除标准
- •Healthy Volunteers:
- •1. Females of childbearing potential, pregnant (confirmed by serum or urine beta
- •human chorionic gonadotropin (ßhCG) test at Screening and prior to dosing) or
- •lactating or planning to become pregnant (self or partner) at any time during the
- •study, including the follow-up period.
- •2. Prior or ongoing medical conditions, medical history, physical findings, or
- •laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could
- •adversely affect the safety of the subject.
- •3. Presence of any underlying physical or psychological medical condition that, in
- •the opinion of the Investigator, would make it unlikely that the subject will comply
- •with the protocol or complete the study per protocol.
- •4. A history of substance abuse or dependency or history of recreational IV drug use
- •over the last 5 years (by self-declaration).
- •5. Blood donation or significant blood loss within 60 days prior to the first study
- •drug administration.
- •ALS Patients:
- •1. Patients with other neuromuscular disorders (in addition to their ALS diagnosis),
- •unless the Investigator determines that such additional disorder will not affect safety or other measures in this study.
- •2. Patients with frontotemporal dementia (FTD).
- •3. Patients with evidence of psychiatric illness or impaired cognitive function which,
- •in the Investigator’s opinion, is likely to prevent them from a full understanding of and/or compliance with the study requirements and procedures.
- •4. Patients with abnormalities detected during the Screening evaluations which, in the Investigator’s medical judgement, are sufficiently significant to exclude them from participation in the study.
- •5. Patients with Type I or poorly controlled Type II Diabetes Mellitus (HbA1c greater than 8%).
研究者
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