Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IkT-001Pro · 1 trial · 1 indication
Area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC0-last)
Area under the concentration-time curve for imatinib from time zero to infinity (AUC(0-inf))
The maximum plasma concentration (Cmax) of imatinib
Incidence and temporal profile of treatment-emergent adverse events (TEAEs)
Proportion of those in each dosing cohort who discontinued the assigned regimen
| Arm | Type | Description |
|---|---|---|
| Dose Calibration | ACTIVE_COMPARATOR | In Part A, cohorts will consist of 8 subjects who will receive a single dose of Ikt-001Pro and then cross over to a single does of imatinib following a 7 day washout. |
| Dose Equivalance | ACTIVE_COMPARATOR | In Part B, up to 16 subjects will receive IkT001-Pro and up to 16 subjects will receive 400mg of imatinib mesylate. After a 7 day washout period the subjects will switch to receive the drug they did not previously receive. |
| Dose Equivalence at 600 mg): | ACTIVE_COMPARATOR | In Part C, up to eight (8) subjects will be administered a single dose of 800 mg IkT-001Pro. After a 7-day washout period, the subjects will switch to 600 mg imatinib. |
| Name | Type | Description |
|---|---|---|
| Imatinib Mesylate | DRUG | 400mg tablet |
| IkT-001Pro | DRUG | 100mg or 400mg tablet |
Inclusion Criteria: 1. Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed. 2. Healthy ambulatory male and female subjects \> 18 to \< 55 years of age at the Screening visit, with no history o...
IkT-001Pro is an investigational small molecule developed for chronic myeloid leukemia (CML), a cancer of the blood and bone marrow. It is being studied as a potential treatment in the oncology therapeutic area. The drug has completed a Phase 1 dose calibration study in CML.
IkT-001Pro targets BCR-ABL, a kinase protein that drives chronic myeloid leukemia. By inhibiting this target, the drug aims to interfere with the abnormal signaling that promotes cancer cell growth in CML. BCR-ABL is the same molecular target addressed by imatinib mesylate.
IkT-001Pro is being developed by Inhibikase Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol IKT. The company is responsible for the clinical development of the drug in chronic myeloid leukemia.
IkT-001Pro is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
IkT-001Pro has been evaluated in one completed Phase 1 trial, NCT05623774, titled "A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg." The study enrolled 64 participants with CML in the United States and used an active-controlled design.