NCT00806338已完成1 期
A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Multiple Dose Tolerance and Pharmacokinetic Study of Trodusquemine (MSI-1436) in Obese or Overweight Type 2 Diabetic Volunteers
Genaera Corporation2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Safety and Tolerance of multiple intravenous doses of trodusquemine (MSI-1436) in obese or overweight type 2 diabetics. Safety will be evaluated by physical exams, vital signs assessments, 12-lead ECGs, clinical lab tests and adverse event profile.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerance of multiple intravenous (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.
详细描述
Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436). Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female obese or overweight type 2 diabetic subjects, between 18 and 65 years old (inclusive) either treatment naïve or who are inadequately controlled on metformin alone;
- •subjects receiving metformin should be on stable dose for at least two weeks prior to enrollment;
- •have a fasting blood sugar of ≥ 100 mg/dL and hemoglobin A1C ≥ 7.5% (but ≤ 11.0%) at study entry;
- •of any race who are in good health (based on medical history, physical examination, electrocardiograms [ECGs], and clinical laboratory tests);
- •non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.,) for 6 months prior to Day 0 of the study. Subjects must have cotinine levels below those measured for smokers based on reference lab values;
- •body mass index (BMI) of 27-40 kg/m2;
- •able to execute informed written consent;
- •willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visits as required by the protocol and as deemed necessary by the Principal Investigator;
排除标准
- •likely allergy or sensitivity to any components of Trodusquemine (MSI-1436C) for Injection;
- •any subject with a history of severe allergy or bronchial asthma;
- •a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular (except hyperlipidemia or controlled hypertension), pulmonary (including chronic asthma), endocrine (except diabetes), central nervous, or hematologic systems, or recent clinically significant surgery;
- •history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions;
- •abnormal pre-admission vital signs, physical examination, clinical laboratory, or any safety variable which is considered clinically significant for this population by the Principal Investigator or Sponsor (or designee). Subjects with an abnormal serum creatinine should not be enrolled. Subjects with AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, blood urea nitrogen (BUN), prothrombin time (PT), or activated partial thromboplastin time (aPPT) >1.5 times above the upper limit of normal should not be enrolled;
- •any subject with a clinically significant mental or physical illness within 1 year prior to the first dose, including a history of alcohol and/or drug abuse within 1 year prior to the first dose of study medication;
- •Insulin requiring diabetics;
- •any subject who has received any known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort, etc.) within a period of 90 days prior to the first dose of study medication;
- •any subject who has received any approved prescription anti-obesity drug or has taken any over-the-counter medication for weight loss or who has received a thiazolidinedione or exanatide within a period of 90 days prior to the first dose of study medication;
- •ingestion or use of any investigational medication or device within 60 days prior to the first dose of study medication; ingestion or use of any investigational anti-obesity medication is prohibited within 3 months prior to the first dose of study medication;
- •any subject with history of malignancy in last 5 years, with exception of basal and squamous cell carcinomas of the skin;
- •any subject who is positive for HBsAG, Hepatitis C antibody, Hepatitis A IgM, or Human Immunodeficiency Virus (HIV) Viral Serology tests at the screening visit;
- •a positive qualitative urine drug or alcohol test at screening or at check-in;
- •mental capacity is limited to the extent that the subject cannot provide legal consent or understand information regarding the study;
- •any subject who has had a 10% weight loss in the past 3 months prior to the screening visit.
研究组 & 干预措施
Trodusquemine (MSI-1436) 3mg/m2
Experimental
干预措施: Trodusquemine (MSI-1436) (Drug)
Trodusquemine (MSI-1436) 6mg/m2
Experimental
干预措施: Trodusquemine (MSI-1436) (Drug)
Trodusquemine (MSI-1436) 10mg/m2
Experimental
干预措施: Trodusquemine (MSI-1436) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerance of multiple intravenous doses of trodusquemine (MSI-1436) in obese or overweight type 2 diabetics. Safety will be evaluated by physical exams, vital signs assessments, 12-lead ECGs, clinical lab tests and adverse event profile.
时间窗: 6 months
次要结局
- Effect on glucose tolerance or glucose/insulin relationships(6 months)
- Effect on appetite and food consumption(6 months)
- Effect on behavior and mood(6 months)
- Effect on exploratory biomarkers(6 months)
研究者
研究点 (2)
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