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

October 12, 2023 updated by: IC-MedTech Corporation

A Phase 1 Non-Randomized Open Label Study of ICM20

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Falls Church, Virginia, United States, 22044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1
ICM20
Drug: ICM20
small molecules
Experimental: Dose Level 2
ICM20 and benznidazole ascending dose 2
Drug: ICM20
small molecules
Drug: Benznidazole
small molecule
Experimental: Dose Level 3
ICM20 and benznidazole ascending dose 3
Drug: ICM20
small molecules
Drug: Benznidazole
small molecule
Experimental: Dose Level 4
ICM20 and benznidazole ascending dose 4
Drug: ICM20
small molecules
Drug: Benznidazole
small molecule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants on study drug at Day 28 and at Day 60
Time Frame: 60 days
Percentage of participants that are still taking the assigned study drug at Day 48 and at Day 60
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 that demonstrate a clinically relevant change from baseline on 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)
Time Frame: 90 days
Percentage of participants with a clinically relevant change from baseline in vital signs
90 days
Percentage of participants with a change from baseline in blood and urine tests
Time Frame: 90 days
Percentage of participants that show a clinically relevant change from baseline
90 days
Percentage of participants with a change from baseline in the electrocardiogram
Time Frame: 90 days
Percentage of participants that show a change in the twelve lead electrocardiogram
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IC-MedTech Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Safety Issues

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe