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

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1 Non-Randomized Open Label Study of Oral ICM20

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IC-MedTech Corporation
• Treatments: Benzonidazole

Criteria

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