NCT05523596CompletedPhase 1
A Phase 1 Non-Randomized Open Label Study of ICM20
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- IC-MedTech Corporation
- Enrollment
- 13
- Locations
- 5
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dose Level 2
Experimental
ICM20 and benznidazole ascending dose 2
Intervention: Benznidazole (Drug)
Dose Level 3
Experimental
ICM20 and benznidazole ascending dose 3
Intervention: Benznidazole (Drug)
Dose Level 4
Experimental
ICM20 and benznidazole ascending dose 4
Intervention: Benznidazole (Drug)
Dose Level 2
Experimental
ICM20 and benznidazole ascending dose 2
Intervention: ICM20 (Drug)
Dose Level 1
Experimental
ICM20
Intervention: ICM20 (Drug)
Dose Level 4
Experimental
ICM20 and benznidazole ascending dose 4
Intervention: ICM20 (Drug)
Dose Level 3
Experimental
ICM20 and benznidazole ascending dose 3
Intervention: ICM20 (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: through study completion, 90 days
Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale
Secondary Outcomes
- 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)
Investigators
Study Sites (5)
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