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

NCT05523596 | Completed Phase 1 FDA Drug

• 1 other identifier: ICM003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of participants on study drug at Day 28 and at Day 60

  60 days

• Percentage of participants with a change from baseline in physical examination based on a review of systems

  90 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

Study Arms (4)

Dose Level 1

EXPERIMENTAL

ICM20

Drug: ICM20

Dose Level 2

EXPERIMENTAL

ICM20 and benznidazole ascending dose 2

Drug: ICM20; Drug: Benznidazole

Dose Level 3

EXPERIMENTAL

ICM20 and benznidazole ascending dose 3

Drug: ICM20; Drug: Benznidazole

Dose Level 4

EXPERIMENTAL

ICM20 and benznidazole ascending dose 4

Drug: ICM20; Drug: Benznidazole

Interventions

ICM20 DRUG

small molecules

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4

Benznidazole DRUG

small molecule

Dose Level 2; Dose Level 3; Dose Level 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• IC-MedTech Corporation: lead

Study Sites (3)

Parkway Medical

Glen Burnie, Maryland, 21061, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Culmore Clinic

Falls Church, Virginia, 22044, United States

Location

MeSH Terms

Interventions

benzonidazole

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 31, 2022
• Study Start: August 20, 2023
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (3)