IkT-148009 for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+35 other locations

Overseen bySydney Kruger

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ABLi Therapeutics, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests the safety and effects of IkT-148009, a daily pill, in people aged 30 to 80 with untreated Parkinson's disease. The drug aims to block an enzyme that may help manage symptoms. Participants will take the drug for a few months.

Eligibility Criteria

This trial is for people aged 30-80 with untreated Parkinson's Disease (PD) who meet specific medical criteria and can self-administer a drug daily with food. They must not need other PD treatments during the study, agree to birth control methods if of childbearing potential, and have no significant health issues that could affect participation.

Inclusion Criteria

I have Parkinson's disease with slow movements and uneven symptoms on both sides.

I am not on any medication for Parkinson's disease.

Montreal Cognitive Assessment ≥ 24

+6 more

Exclusion Criteria

I have advanced or intermediate age-related vision loss.

I experience significant dizziness when standing up.

I haven't taken Parkinson's disease medications or supplements for over 28 days.

+21 more

Participant Groups

The trial tests IkT-148009's safety and how it affects the body compared to a placebo in managing Parkinson's symptoms. Participants will randomly receive either one of three doses of IkT-148009 or a placebo once daily for 12 weeks.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 50mg IkT-148009Experimental Treatment1 Intervention

This arm will consist of thirty (30) patients on 50mg of active treatment.

Group II: 200mg IkT-148009Experimental Treatment1 Intervention

This arm will consist of thirty (30) patients on 200mg of active treatment.

Group III: 100mg IkT-148009Experimental Treatment1 Intervention

This arm will consist of thirty (30) patients on 100mg of active treatment.

Group IV: PlaceboPlacebo Group1 Intervention

This arm will consist of thirty (30) patients on placebo.