A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults

This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole

Inclusion criteria

• ≥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

Exclusion criteria

• 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