A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults
- Registration Number
- NCT05523596
- Lead Sponsor
- IC-MedTech Corporation
- Brief Summary
A Phase 1 Non-Randomized Open Label Study of Oral ICM20
- Detailed Description
This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
- ≥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
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Level 1 ICM20 ICM20 Dose Level 2 ICM20 ICM20 and benznidazole ascending dose 2 Dose Level 2 Benznidazole ICM20 and benznidazole ascending dose 2 Dose Level 3 ICM20 ICM20 and benznidazole ascending dose 3 Dose Level 4 ICM20 ICM20 and benznidazole ascending dose 4 Dose Level 3 Benznidazole ICM20 and benznidazole ascending dose 3 Dose Level 4 Benznidazole ICM20 and benznidazole ascending dose 4
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events through study completion, 90 days Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale
- Secondary Outcome Measures
Name Time Method Percentage of participants with a change from baseline in physical examination based on a review of systems 90 days Percentage of participants that demonstrate a clinically relevant change from baseline on physical examination based on a review of systems
Percentage of participants on study drug at Day 28 and at Day 60 60 days Percentage of participants that are still taking the assigned study drug at Day 48 and at Day 60
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 clinically relevant change from baseline in vital signs
Percentage of participants with a change from baseline in blood and urine tests 90 days Percentage of participants that show a clinically relevant change from baseline
Percentage of participants with a change from baseline in the electrocardiogram 90 days Percentage of participants that show a change in the twelve lead electrocardiogram
Trial Locations
- Locations (3)
Culmore Clinic
🇺🇸Falls Church, Virginia, United States
Parkway Medical
🇺🇸Glen Burnie, Maryland, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States