A Phase I, Randomized Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Determine the Safety, Tolerability, and Pharmacokinetics (PK) of IkT-148009 in Elderly Subjects

Not Yet Recruiting
Inhibikase Therapeutics, Inc.
Study Design: 
This is a phase 1, randomized, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of IkT-148009. The study will include elderly, otherwise healthy individuals between the age of 55 to 70 years. The study will have two parts. In part A, single ascending dose, there will be 8 participants in each cohort. Six will receive the investigational drug, and two will receive placebo. Participants will be observed for four days. In part B, cohorts will consist of 12 participants, of which nine will be assigned to the investigational drug. Sentinel dosing will be employed for each cohort, and dose escalation will be undertaken after reviewing the preceding dose’s safety data.
Primary outcome measures focus on safety and measure vital signs, clinical laboratory data, electrocardiogram, Columbia suicide severity rating scale, adverse events. Pharmacokinetic measurements will include maximum concentration, time to reach maximum concentration and half-life. An exploratory measure will look at the CSF drug concentration for multiple ascending doses.
IkT-148009 is another c-Abl kinase inhibitor being developed as a potential disease-modifying agent for PD. The molecule is still in the early phase and is being evaluated for safety and tolerability at this time. Unlike FB-101, this molecule is being evaluated in elderly otherwise healthy individuals. The study will also assess brain penetrance of the drug by CSF measurement.