Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease

A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease

The purpose of this study in healthy adult males is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594.

The purpose of this study in patients with Parkinson's disease is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of KDT-3594 will also be investigated.

Inclusion Criteria:

• Healthy volunteer part

  • Healthy Japanese males aged 20 to 35 years, inclusive

• Patient part

  • Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
  • Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
  • Male patients with Parkinson's disease aged 20 to 74 years inclusive, post-menopausal female patients with Parkinson's disease aged 50 to 74 years inclusive

Exclusion Criteria:

• Healthy volunteer part

  • Subjects with any abnormal findings in physical examination vital signs, 12-lead ECG, clinical laboratory tests, ophthalmic examinations and electroencephalography

• Patient part

  • Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease

• Healthy volunteer part and patient part

  • Subjects who do not agree to avoid dangerous works such as driving, mechanical operation and high-place work until completion of the follow-up examination