This is a two centre, double-blind, randomised, placebo-controlled, multiple ascending dose study in patients with mild to moderate Parkinson´s disease. It is planned to enrol up to 5 cohorts. Cohorts A-C consist of up to 8 subjects. In Cohorts A and B, subjects will be randomly assigned to receive multiple ascending oral doses of anle138b or matching placebo (6 active investigational medicinal product [IMP], 2 placebo per cohort in cohorts A-C) for 7 days in a sequential escalating manner. Subjects in cohort A and B will be dosed once dialy and subjects in cohort C will be dosed twice a day. Subjects in Cohorts A and B will also receive an additional single oral dose of active IMP or matching placebo on Day 9 of the study for an assessment of the effect of food on the PK of anle138b in PD patients. Subjects in cohort D will be randomly assigned to receive QD doses of anle138b or matching placebo (placebo vs 150 mg vs 300 mg; 1:1:1) for 7 days in fasted state. Subjects in Cohort E will be randomly assigned to receive QD doses of either 300 mg anle138b or matching placebo (1:1) for 28 days taken in the non-fasted state.
The purpose of this study is to determine the safety, tolerability and blood levels of orally administered anle138b as well as the effect of food and early signs of efficacy in patients with mild to moderate Parkinson´s disease.