Last updated on February 2018

KM-819 for Patients With Parkinson's Disease


Brief description of study

This first in human, single-center, randomized, placebo-controlled, double blind, sequential group Phase 1 study in healthy subjects will be conducted to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) following the escalation of single and multiple doses of KM-819.

The study will consist of 2 parts. In Part A, up to 5 cohorts of young adult male subjects, and 1 single dose cohort of elderly male or post menopausal female subjects will receive escalating single doses of KM-819. The food effect will be investigated in one of the single dose cohorts of young adult male subjects, who will be crossed-over to the fed condition. Once the dose level is selected for the crossed-over to the fed condition and elderly subjects, the protocol will be amended to specify the dose level. In Part B, up to 4 cohorts of healthy young adult male subjects and 1 multiple dose cohort of elderly male or post menopausal female subjects will receive escalating multiple doses of KM-819. Part B will be conducted after completion of all cohorts of young adult male subjects in Part A.

Dose escalation to the next level will be determined using safety, tolerability, and PK data of the previous cohort.

Part A, Single Ascending Dose (SAD) Up to 40 healthy young adult male subjects and 8 healthy elderly male or post menopausal female subjects will be enrolled and randomized to receive either KM-819 or placebo.

Each of the 5 dose escalation cohorts consists of 8 healthy young adult male subjects; 6 subjects will receive 10, 30, 100, 200, or 400 mg of KM-819 and 2 subjects will receive placebo. In each single dose cohort, dosing of subjects will be sentinel, i.e., 2 subjects will be dosed on the first day (1 subject will receive active treatment and 1 subject will receive placebo) and the remaining 6 subjects will be dosed at least 24 hours after the first 2 subjects.

Cohorts will be dosed sequentially with escalating doses. One of the cohorts will be crossed-over to the fed condition to assess the effect of food as decided by Investigator and Sponsor during the study after completion of the 2nd dose cohort (30 mg).

Eight elderly male or post-menopausal female subjects will be enrolled into an additional cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested in the young adult male cohorts and 2 subjects will receive placebo.

Part A consists of a Screening period of up to 28 days, and a 3 day Confinement period when subjects are hospitalized for study activities. Subjects are required to return for outpatient visits on Day 4, 7 and for the Follow up Visit on Day 14. The cohort that crossed-over to the fed condition will undergo the same procedure up to the Outpatient Visit on Day 4. Subjects will be confined for 3 days for the second time, and are required to return for outpatient Visit 5 (Day 4), Visit 6 (Day 7), and for a Follow up Visit 7 (Day 14).

Part B, Multiple Ascending Dose (MAD) Up to 32 healthy young adult male subjects and 8 healthy elderly male or post menopausal female subjects will be enrolled and randomized to receive either KM-819 or placebo.

Each of the 4 dose escalation cohorts consists of 8 healthy young adult male subjects; 6 subjects will receive 30, 100, 200, or 400 mg of KM-819 once a day (QD) for 7 days and 2 subjects will receive placebo. Cohorts will be dosed sequentially with escalating doses.

Eight elderly male or post-menopausal female subjects will be enrolled into an additional cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested in the young adult male cohorts and 2 subjects will receive placebo.

Clinical Study Identifier: NCT03022799

Contact Investigators or Research Sites near you

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Kyoung Soo Lim, MD, PhD

CHA Bundang Medical Center, CHA University
Seongnam, Korea, Republic of
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