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New chagas drug candidate passes first safety test in small trial

NCT ID NCT05523596

Disease control Sponsor: IC-MedTech Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested the safety of an experimental drug called ICM20 in 13 adults with Chagas disease who had not been treated before. Participants took ICM20 along with the standard drug benznidazole. The main goal was to check for side effects and see how many people stayed on the medication for 60 days. Since this was a small safety study, it does not yet show whether ICM20 works better than existing treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ICM20 (a small molecule drug) and benznidazole (a standard Chagas drug)
What this could lead to
If safe, this could support further studies of ICM20 for treating Chagas disease.
What could go wrong
This is a very early Phase 1 safety trial with only 13 participants, so it cannot prove effectiveness. Side effects or lack of benefit may emerge in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Aug 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Chagas disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Safety issues

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Culmore Clinic

    Falls Church, Virginia, 22044, United States

  • Parkway Medical

    Glen Burnie, Maryland, 21061, United States

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