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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2027-03-31

Brief Summary

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

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Detailed Description

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

Conditions

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Safety Issues

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

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ICM20

small molecules

Intervention Type DRUG

Benznidazole

small molecule

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No