Safety IssuesPhase 1NCT05523596
A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults
A Phase 1 study testing ICM20 and Benznidazole in people with Safety Issues, run by IC-MedTech Corporation at 3 sites in United States.
Trial summary
A Phase 1 Non-Randomized Open Label Study of Oral ICM20 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- ICM20 and Benznidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Aug 2023to 3 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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:
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- 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
Who cannot join
- 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
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- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Culmore Clinic
Falls Church, Virginia, 22044
Parkway Medical
Glen Burnie, Maryland, 21061
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: A Phase 1 Non-Randomized Open Label Study of ICM20
A Phase 1 Non-Randomized Open Label Study of Oral ICM20
Read the detailed description
This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole
- Conditions
- Safety Issues
- Being tested
- ICM20, Benznidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICM20Drug
small molecules
BenznidazoleDrug
small molecule
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | ICM20 Receives: Drug: ICM20 |
| Dose Level 2 | Experimental | ICM20 and benznidazole ascending dose 2 Receives: Drug: ICM20; Drug: Benznidazole |
| Dose Level 3 | Experimental | ICM20 and benznidazole ascending dose 3 Receives: Drug: ICM20; Drug: Benznidazole |
| Dose Level 4 | Experimental | ICM20 and benznidazole ascending dose 4 Receives: Drug: ICM20; Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale
Measured: through study completion, 90 days
Secondary outcomes (5)
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
Measured: 60 days
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
Measured: 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)
Percentage of participants with a clinically relevant change from baseline in vital signs
Measured: 90 days
Percentage of participants with a change from baseline in blood and urine tests
Percentage of participants that show a clinically relevant change from baseline
Measured: 90 days
Percentage of participants with a change from baseline in the electrocardiogram
Percentage of participants that show a change in the twelve lead electrocardiogram
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start20 Aug 2023
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- IC-MedTech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523596
- Sponsor's protocol ID
- ICM003
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Non-Randomized Open Label Study of ICM20
- ClinicalTrials.gov ID
- NCT05523596
- Acronym / sponsor ID
- ICM003
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- IC-MedTech CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 Non-Randomized Open Label Study of Oral ICM20
Detailed description
This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: ICM20ICM20 |
| Dose Level 2 | Experimental | Drug: ICM20, Drug: BenznidazoleICM20 and benznidazole ascending dose 2 |
| Dose Level 3 | Experimental | Drug: ICM20, Drug: BenznidazoleICM20 and benznidazole ascending dose 3 |
| Dose Level 4 | Experimental | Drug: ICM20, Drug: BenznidazoleICM20 and benznidazole ascending dose 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICM20small molecules | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 |
| Benznidazolesmall molecule | Drug | Dose Level 2, Dose Level 3, Dose Level 4 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, 90 days
Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale
5 secondary outcomes
Percentage of participants on study drug at Day 28 and at Day 60
Time frame: 60 days
Percentage of participants with a change from baseline in physical examination based on a review of systems
Time frame: 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)
Time frame: 90 days
Percentage of participants with a change from baseline in blood and urine tests
Time frame: 90 days
Percentage of participants with a change from baseline in the electrocardiogram
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICM20 and Benznidazole in people with Safety Issues, run by IC-MedTech Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: through study completion, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.