A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Administration Phase 1 Clinical Trial to Evalute the Satety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of MT1013 Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single ascending dose administration phase one clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of MT1013 injection in healthy subjects.
详细描述
This will be a single center, Phase 1, randomized, double-blind single-dose, sequential SAD study.
This SAD study will consist of up to 5 cohorts (1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving the active study drug and 2 subjects receiving matching placebo).
A staggered dosing schedule will be used for each dose level administered under fasting conditions. Two (2) sentinel subjects (1 active and 1 placebo) will be dosed first (a minimum of 1 hour apart) and the remaining 6 subjects will be dosed no sooner than the next day (each dosed at least 15 minutes apart).
Following completion of each dose level, a SRC will review the safety and tolerability data as well as the available PK data up to 48 hours in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be double-blinded. The subjects and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the subject's treatment assignment (MT1013 or placebo). Blinding will be maintained until at least the clinical phase of the study is completed。
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
- •Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with BMI >18.0 and <30.0 kg/m2 and body weight ≥45.0 kg for males and females.
- •Healthy as defined by:
- •the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- •the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, GI, renal, hepatic, and metabolic disease.
- •Females of childbearing potential who are sexually active with a non-sterile male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
- •Capable of consent.
排除标准
- •Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, hepatitis C, or Treponema pallidum antibody found during medical screening.
- •Positive urine drug screen or urine cotinine test or alcohol breath test at screening.
- •Positive fecal occult blood test at screening.
- •History of clinically significant drug allergies.
- •Positive pregnancy test at screening.
- •Clinically significant ECG abnormalities (QTcF ≥450 ms) or a family history of long QT syndrome.
- •Clinically significant vital sign abnormalities at screening.
- •History of significant alcohol abuse within 1 year prior to screening.
- •History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days or 5 half-lives (whichever is longer) prior to the first dosing.
- •Use of prohibited medications for the timeframes specified.
- •Donation of plasma within 7 days prior to dosing.
- •Breast-feeding subject.
- •The combination of diseases that may affect the assessment of drug absorption, distribution, metabolism, excretion and safety data, or that can reduce compliance.
- •Subjects with previous clinically significant history of epileptic seizures.
研究组 & 干预措施
1st cohort
MT1013 injection at 2.5 mg.
干预措施: MT1013 (Drug)
2nd cohort
MT1013 injection at 5 mg.
干预措施: MT1013 (Drug)
3rd cohort
MT1013 injection at 10 mg.
干预措施: MT1013 (Drug)
4th cohort
MT1013 injection at 15 mg.
干预措施: MT1013 (Drug)
5th cohort
MT1013 injection at 20 mg.
干预措施: MT1013 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects.
时间窗: Three months
Assessment of adverse events
次要结局
- PK(3 days)
- To characterize the pharmacodynamics (PD) of MT1013 for injection in healthy adult subjects(3 days)
- PD(3 days)
- To characterize the pharmacokinetics (PK) of MT1013 for injection in healthy adult subjects(3 days)