NCT02828046已完成1 期
A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single (Part 1) and Multiple (Part 2) Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of M281 Administered to Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Counts and Percentages of adverse events by treatment group
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between 18 and 55 years, inclusive.
- •Good health
- •Body weight between 50 and 110 kg inclusive
排除标准
- •History of any drug allergy, hypersensitivity, or intolerance to any drug product that in the opinion of the Investigator would place the subject at particular risk and compromise the safety of the subject in the study.
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, psychiatric disease, or any other condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
- •History or current diagnosis of substance dependence (except nicotine and caffeine) or alcohol abuse over the past 2 years, according to the criteria of DSM-IV-TR.
- •Smokes or has smoked more than 5 cigarettes per day in the last 90 days and is unable to stop smoking during in-patient observation period in clinic.
- •Unwillingness to abstain from alcohol for at least 24 hours prior to dosing with study medication until the time of discharge from the study unit and at least 24 hours prior to each ambulatory visit.
- •Plans to participate in another clinical trial while enrolled in this study and/or received an investigational drug and/or device within 60 days prior to admission.
- •Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to admission.
- •History of splenectomy, asthma (with the exception of childhood asthma that has resolved), COPD, recurrent or current GI or respiratory infections.
- •On fluid restriction.
- •Systemic steroids within 3 months prior to the start of study drug administration, or any prescription medication(s) within 14 days of dose administration or any non-prescribed systemic or topical medication (including any herbal product) within 7 days prior to dose administration.
- •Vaccination within 1 month before dosing, or plans to receive vaccination during the study.
- •Any illness within 5 days, or clinically significant airway infections within 30 days, prior to first study drug dosing.
- •Positive urine drug screen (UDS) at screening.
- •Positivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at screening.
结局指标
主要结局
Counts and Percentages of adverse events by treatment group
时间窗: Baseline until up-to 12 weeks post-dose
次要结局
- Serum concentrations of M281 will be summarized using descriptive statistics (arithmetic means, SDs, coefficients of variation, sample size, minimum, maximum, and geometric means).(Baseline up-to 12 weeks post-dose)
- PD of M281 will summarize changes in serum markers of inflammation.(Up until 12 weeks post dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia GravisGeneralized Myasthenia GravisNCT03772587Momenta Pharmaceuticals, Inc.68
已完成
1 期
Phase 1 SAD and MAD Study of NGM282 in Healthy Adult ParticipantsDiabetes MellitusNCT01776528NGM Biopharmaceuticals, Inc119
已完成
1 期
A Safety Study of LY2886721 Multiple Doses in Healthy SubjectsAlzheimer's DiseaseNCT01227252Eli Lilly and Company42
终止
1 期
A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)Advanced Solid TumorsNCT05394350Merck Sharp & Dohme LLC27
已完成
2 期
Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent SubjectsADHD, Predominantly Inattentive TypeNCT02189772Alcobra Ltd.83