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IkT-001Pro vs Imatinib for Chronic Myeloid Leukemia
Study Summary
This trial tests the safety and effectiveness of a new drug, IkT-001Pro, compared to imatinib mesylate in healthy volunteers. Data from Part A will be used to select Part B which will assess bioequivalence.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I have a significant medical history or current serious health issues.I am between 18 and 55 years old and in good health with no serious medical issues.I am willing to avoid donating sperm.I have tested positive for hepatitis B, C, or HIV.I agree to use a highly effective method of birth control.I am a woman who cannot become pregnant, am not pregnant, not breastfeeding, and use strong birth control.My recent physical exam or ECG showed significant abnormalities.I am not taking medication that affects drug metabolism.My kidney function is reduced with a creatinine clearance rate below 90 mL/min.My weight is over 50 kg and my BMI is between 18.0 and 32.0.I have been treated with or am allergic to imatinib.
- Group 1: Dose Calibration
- Group 2: Dose Equivalance
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the intent behind this clinical experiment?
"This medical trial, which will run from day 1 to 12, is intended to measure the proportion of patients who drop out in each dosing cohort. Secondary objectives include assessing imatinib exposure after administration via IkT-001Pro and mesylate through peak concentration (Cmax/D), time it takes for maximal concentration (tmax) and terminal half life (t1/2)."
Does this research permit elderly individuals to participate?
"This clinical trial stipulates that participants must be at least 18 years old and no older than 55."
How many participants are taking part in this research endeavor?
"Affirmative. According to information found on clinicaltrials.gov, this research endeavour is still recruiting participants after its initial listing date of November 30th 2022; the entry was most recently edited on the 21st of November 2022. The study requires 64 patients from 1 medical centre."
Are there openings to participate in this research initiative at present?
"According to clinicaltrials.gov, this trial is still recruiting participants and was initially announced on November 30th 2022 with a recent update occurring on the 21st of that same month."
Has Dose Calibration obtained sanction from the FDA?
"Due to the lack of data surrounding safety and efficacy, we have rated Dose Calibration as a 1 on our scale from 1-3."
What qualifications must prospective participants have to be considered for this experiment?
"For this medical trial, 64 adults aged 18 to 55 with chronic myeloid leukemia are being sought. To be eligible, they must have answered all questions and signed a consent form prior to any procedures, weigh more than 50 kgs with a BMI between 18.0 and 32.0kg/m2 at the screening visit; display normal physical examination values as well as vital signs and clinical laboratory results deemed non-clinically significant by the PI; male participants should agree to use highly effective birth control for seven days after receiving their last dose of study drug or abstain from sperm donation during that period while female participants must either be"
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