NCT06934941招募中1 期
A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NM-101
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetic profile of NM-101 after a single iv infusion
研究概览
简要总结
Phase 1, double-blind, placebo-controlled, single-centre, single ascending dose escalation study to assess safety and tolerability of a monoclonal antibody, NM-101 in healthy volunteer subject and multiple system atrophy (MSA) patients.
详细描述
Phase 1, double-blind, placebo-controlled, single-centre, single ascending dose escalation study to assess safety and tolerability of a monoclonal antibody, NM-101 in healthy volunteer subject and multiple system atrophy (MSA) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male Healthy subjects, 18 to 60 years of age and in good health with no clinically significant abnormality identified on the medical history, physical examination or laboratory evaluation at screening
- •Body weight≥ 45kg and body mass index between 18 - 30 kg/m2
- •Normal blood pressure (systolic >90 and <140 mmHg, diastolic >40 and <90mmHg) and pulse rate 40-100bpm at screening visit. Blood pressure and pulse are measured after 3 minutes in supine position
- •Baseline QTc must be <450msec for men and <470msec for women
- •Normal 12-lead electrocardiogram at screening
- •No clinically significant abnormal laboratory test values at screening
- •No clinically significant findings on the clinical neurological and ophthalmic examinations at screening and at baseline
- •Good venous access in both arms
- •Willing to consent to participate in study prior to study specific screening procedures with the understanding that the subject has the right to withdraw from the study at any time without prejudice
- •Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months after the dosing of NM-101.
排除标准
- •History of serious adverse reaction or hypersensitivity to biological agents including immunoglobulins
- •Presence or history of any allergy requiring acute or chronic treatment; seasonal allergic rhinitis can be permitted unless the subject is taking systemic medication (nasal spray or local treatments permitted). Subjects having clinically significant drug or food allergies are also excluded.
- •History of autoimmune or inflammatory disease
- •Clinically significant (i.e., active) cardiovascular disease (e.g., hypertension, arrhythmia, myocardial infarction, heart failure, long QT syndrome or other conditions causing prolongation of the QT/QT interval corrected with Fridericia's formula [QTcF]) prior to screening.
- •History of cerebral vascular accident or stroke. Subjects having high risk of developing a stroke are also excluded.
- •History or positive test results at screening for human immunodeficiency virus (HIV), hepatitis B, hepatitis C
- •Positive in tuberculosis screening test (Quantiferon test)
- •Active infection within 4 weeks from screening and body temperature >38℃
- •Active immunization within 3 months prior to dosing of NM-101
- •History or clinically significant evidence of cardiovascular, endocrine (e.g. diabetes mellitus), respiratory, renal, hepatic, gastrointestinal, haematological neurologic, psychiatric or other disease
- •Chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary track
- •History or presence of malignancy including solid tumors and hematologic malignancies except for basal cell and squamous cell carcinoma of the skin that had been completely excised and were considered cured with no evidence of disease ≥ 3 years
- •Participation in a clinical study during the previous 24 weeks i.e. from completion of the previous study to the planned first administration of the current study
- •Loss of >500mL blood including blood donation within 12 weeks prior to screening visit
- •Intake more than 24 units of alcohol per week (1 unit=250mL of beer, 100mL of wine or 35mL of spirits)
- •Smokers >5 cigarettes or the equivalent in tobacco daily. Must have been willing to abstain from using tobacco and tobacco-containing products for 72 hours prior to the dosing of NM-101 and during the inpatient monitoring period.
- •Treatment with any prescription medication and/or over-the-counter products (excluding acetaminophen, hormone replacement therapy (HRT) and birth control) within 30 days prior to dosing of NM-
- •Routine vitamin therapy is allowed.
- •History of drug or alcohol abuse within the past 5 years, a positive urine drug test and/or a positive alcohol urine test at Screening visit
- •Surgery other than minor cosmetic surgery and minor dental surgery within 3 months from the screening visit
- •History of lumbar surgery for any reasons (e.g., herniated disc) or other contraindications to having al lumbar puncture (LP)
- •Vigorous physical exercise 48 hours prior to screening
- •Women with a positive pregnancy test at screening
- •Women who are breast feeding
研究组 & 干预措施
NM-101
Experimental
NM-101 iv
干预措施: NM-101 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
时间窗: Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12
Clearance rate of drug
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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