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

Safety Issues Clinical Trial

Official title:

A Phase 1 Non-Randomized Open Label Study of ICM20

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523596
• Other study ID #: ICM003
• Status: Recruiting
• Phase: Phase 1
• Start date: December 20, 2022
• Est. completion date: March 2027

Study information

• Verified date: October 2023
• Source: IC-MedTech Corporation
• Contact: IC-MedTech Medical Affairs
• Phone: 301-469-4867
• Email: ICM.ctgov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety Issues

Intervention

Drug:
• ICM20
small molecules
• Benznidazole
small molecule

Locations

Country	Name	City	State
United States	Culmore Clinic	Falls Church	Virginia
United States	Parkway Medical	Glen Burnie	Maryland
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
IC-MedTech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale	through study completion, 90 days
Secondary	Percentage of participants on study drug at Day 28 and at Day 60	Percentage of participants that are still taking the assigned study drug at Day 48 and at Day 60	60 days
Secondary	Percentage of participants with a change from baseline in physical examination based on a review of systems	Percentage of participants that demonstrate a clinically relevant change from baseline on physical examination based on a review of systems	90 days
Secondary	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)	Percentage of participants with a clinically relevant change from baseline in vital signs	90 days
Secondary	Percentage of participants with a change from baseline in blood and urine tests	Percentage of participants that show a clinically relevant change from baseline	90 days
Secondary	Percentage of participants with a change from baseline in the electrocardiogram	Percentage of participants that show a change in the twelve lead electrocardiogram	90 days