NCT04350177

A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants and Parkinson's Patients

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 Older Adult and Elderly Healthy Volunteers With Extension Into Parkinson's Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: ABLi Therapeutics, Inc. · Industry
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study investigates the safety and tolerability of drug IkT-148009 in healthy elderly volunteers (55 to 70 years old). This first-in-human study is designed in 3 parts. In Part A, healthy participants will take a single, oral dose of IkT-148009 or placebo. Part A participants will be at the study site for approximately 4 days. In Part B, healthy participants will take an oral dose of IkT-148009 once a day for 7 days. Part B participants will be at the study site for approximately 12 days. In Part C, Parkinson\'s patients will take an oral dose of IkT-148009 once a day for 7 days. Part C participants will be at the study site for approximately 12 days.

Detailed description

This is a randomized, Phase 1 study in older adult or elderly healthy volunteer subjects with subsequent extension into Parkinson patients to identify the safety, tolerability, maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of IkT-148009 capsules given as single or multiple doses. In Part A (SAD) cohorts will consist of eight (8) subjects, six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo. Sentinel dosing will be employed on the first day of each cohort, with one subject randomized to receive IkT-148009 and the other placebo. These two subjects in each cohort will be monitored for 48 hours after dosing before deciding to dose the remainder of the cohort. The other six subjects in the first cohort will be dosed approximately 48 hours later. Each cohort will be monitored for at least 48 hours before deciding whether to administer drug to the sentinel pair for the next cohort. Each cohort will be dosed at approximately weekly intervals to allow adequate time for collection and review of safety and PK data. A Safety Review Committee (SRC) will evaluate all available safety, tolerability, and PK data for each cohort. Escalation to a next dose will be undertaken only after these data have been reviewed by the SRC and agreement reached that it is safe to increase the dose. The SRC will not receive any unblinded PK data unless they agree to unblind a subject and/or cohort based on the completed safety review. In Part B (MAD) cohorts will consist of eight (8) subjects, six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo daily for up to seven consecutive days. Subjects in each cohort will be observed for 48 hours after their last dose before deciding to initiate the next (higher dose) cohort. Each cohort will be dosed at approximately weekly intervals in order to allow adequate time for collection and review of safety and PK data. At the discretion of the SRC, MAD cohorts may be added consisting of eligible participants with Parkinson's Disease (Part C). In Part C (MAD with Parkinson\'s Disease) eligible PD participants will arrive the evening before initiation of study drug dosing. No Parkinsonism medications will be given after midnight, the following morning potential participants will be clinically assessed in the practically-defined OFF state using MDS-UPDRS Part III. Cohorts will consist of eight (8) subjects, six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo daily for up to seven consecutive days. Subjects in each cohort will be observed for 48 hours after their last dose before deciding to initiate the next (higher dose) cohort. Each cohort will be dosed at approximately weekly intervals in order to allow adequate time for collection and review of safety and PK data.

Conditions

• Healthy Elderly
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	IkT-148009	Oral administration gelatin capsule
DRUG	Placebo	Oral administration gelatin capsule

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-10-30
• Completion: 2023-01-30
• First posted: 2020-04-16
• Last updated: 2025-03-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study