CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease

United States137 participantsStarted 2023-05-15

Plain-language summary

This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com

Who can participate

Age range30 Years – 80 Years

SexALL

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Inclusion criteria

✓. Participants who are diagnosed with PD consistent with UK Brain Bank criteria and MDS Research Criteria; must include bradykinesia with sequence effect and motor asymmetry.
✓. Receiving no anti-parkinsonian therapy
✓. Modified Hoehn/Yahr Stage \< 3.0
✓. Montreal Cognitive Assessment ≥ 24
✓. Patient expected to be able to participate in trial without need for additional anti-parkinsonian therapy
✓. Male participants must agree to practice an acceptable method of highly effective birth control from the screening visit, while on study and for 30 days after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence, vasectomy, or a condom with spermicide (men) in combination with their partner's highly effective method.
✓. Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and at least 30 days after the last dose of study drug has been taken.

Exclusion criteria

What they're measuring

Incidence of Treatment-emergent Adverse Events (TEAEs)

Timeframe: Baseline to 12 weeks

Proportion of Those Randomized in Each Dosing Cohort Who Discontinued the Assigned Regimen Due to an Adverse Event

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT05424276

SponsorABLi Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-25

Results submitted2025-09-16

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