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 being developed for the treatment of chronic myeloid leukemia (CML). It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with CML, and it has received orphan drug designation from the FDA.
IkT-001Pro is a small molecule developed for CML. The specific molecular target of IkT-001Pro is not disclosed in the available information. The drug is being studied in a Phase 1 clinical trial comparing it to imatinib mesylate 400mg, which is a standard treatment for CML.
IkT-001Pro is being developed by Inhibikase Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IKT. Inhibikase is conducting clinical trials to evaluate the safety and efficacy of IkT-001Pro in patients with chronic myeloid leukemia.
IkT-001Pro is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received orphan drug designation from the FDA for the treatment of CML. A Phase 1 clinical trial has been completed, and the drug remains in early-stage development.
IkT-001Pro has one completed Phase 1 clinical trial, identified as NCT05623774. This trial was a dose calibration study comparing IkT-001Pro to imatinib mesylate 400mg in healthy volunteers and patients with CML. The trial enrolled 64 participants and was conducted in the United States.
No, IkT-001Pro is not the same as imatinib. IkT-001Pro is an investigational drug being developed by Inhibikase Therapeutics, while imatinib mesylate is an approved treatment for CML. The Phase 1 clinical trial NCT05623774 compared IkT-001Pro to imatinib mesylate 400mg to calibrate dosing.