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

IC-MedTech

Status and phase: Active, not recruiting; Phase 1

Conditions: Safety Issues

Treatments: Drug: Benznidazole; Drug: ICM20

Study type: Interventional

Funder types: Industry

Identifiers

NCT05523596

ICM003

Details and patient eligibility

About

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

Full description

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Dose Level 1

Experimental group

Description:

ICM20

Treatment:

Drug: ICM20

Dose Level 2

Experimental group

Description:

ICM20 and benznidazole ascending dose 2

Treatment:

Drug: ICM20

Drug: Benznidazole

Dose Level 3

Experimental group

Description:

ICM20 and benznidazole ascending dose 3

Treatment:

Drug: ICM20

Drug: Benznidazole

Dose Level 4

Experimental group

Description:

ICM20 and benznidazole ascending dose 4

Treatment:

Drug: ICM20

Drug: Benznidazole