NCT05523596已完成1 期
A Phase 1 Non-Randomized Open Label Study of ICM20
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
A Phase 1 Non-Randomized Open Label Study of Oral ICM20
详细描述
This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 to 70 years of age
- •≥125 and ≤200 pounds
- •Diagnosis of chagas documented by positive serology
- •No prior chagas treatment
- •Able to swallow capsules and tablets
- •Laboratory values:
- •Blood: Hemoglobin ≥9; Polymorphonuclear white blood cells >1000; Platelets >50,000 Liver Function Tests ≤ 2 Times Upper Limit of Normal Serum Creatinine ≤2.0 Prothrombin time, partial thromboplastin time within normal limits HemoglobinA1C <7
- •Human immunodeficiency virus negative
- •Stable on current prescription medications
- •Not pregnant, lactating, or planning to get pregnant
- •Both men and women who are not surgically sterile, or post-menopausal, must agree to avoid pregnancy
- •Willing to abstain from alcohol
- •Able and willing to give informed consent
排除标准
- •Prior chagas treatment
- •Known hypersensitivity to either study drug or its constituents
- •Requires the continuing use of amiodarone, monoamine oxidase inhibitors, phenytoin, phenobarbital, disulfiram, anticoagulants or procoagulants, drugs or products containing alcohol or propylene glycol.
- •Coagulopathy
- •Glucose-6-phosphate dehydrogenase deficiency
- •History, signs, or symptoms of heart failure
- •History of heartburn, gastroesophageal reflux disease, or ulcers
- •Unstable medical condition
- •Immunodeficiency
- •Requires surgery or surgical procedure within 90 days of Screening.
- •Use of an investigational product within 56 days prior to baseline
- •Unwilling to discontinue use of disallowed products
- •Unable to give informed consent
研究组 & 干预措施
Dose Level 2
Experimental
ICM20 and benznidazole ascending dose 2
干预措施: Benznidazole (Drug)
Dose Level 3
Experimental
ICM20 and benznidazole ascending dose 3
干预措施: Benznidazole (Drug)
Dose Level 4
Experimental
ICM20 and benznidazole ascending dose 4
干预措施: Benznidazole (Drug)
Dose Level 2
Experimental
ICM20 and benznidazole ascending dose 2
干预措施: ICM20 (Drug)
Dose Level 1
Experimental
ICM20
干预措施: ICM20 (Drug)
Dose Level 4
Experimental
ICM20 and benznidazole ascending dose 4
干预措施: ICM20 (Drug)
Dose Level 3
Experimental
ICM20 and benznidazole ascending dose 3
干预措施: ICM20 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: through study completion, 90 days
Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale
次要结局
- Percentage of participants with a change from baseline in physical examination based on a review of systems(90 days)
- Percentage of participants on study drug at Day 28 and at Day 60(60 days)
- Percentage of participants with a change from baseline in vital signs (temperature in degrees Fahrenheit, respiratory rate in breaths per minute, heart rate in beats per minute, blood pressure in millimeters mercury)(90 days)
- Percentage of participants with a change from baseline in blood and urine tests(90 days)
- Percentage of participants with a change from baseline in the electrocardiogram(90 days)
研究者
研究点 (5)
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