Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease

Exclusion criteria

• . Predicted poor compliance with study procedures, restrictions and requirements.
• . Veins unsuitable for repeated venepuncture or cannulation.
• . History or evidence of current clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, haematological, metabolic-endocrine, neurological, urogenital or psychiatric disorder. Subjects with any type of generalized seizures in adulthood must be excluded. Personal or first-degree family history of congenital long QT syndrome or sudden death of a first-degree relative suspected to be due to long QT syndrome will also exclude the subject.
• . MRI (3 T) of the brain with indication of clinically significant CNS disorder.
• . History of any type of cancer, except for the age group of above 65 years, where a history of successfully treated cancer, with at least 5 years since the end of treatment, or local prostate cancer with no evidence of disease progression under adequate active surveillance, may be allowed at the investigator's discretion.
• . Susceptibility to severe allergic reactions, e.g. history of anaphylactic shock due to any reason.
• . Any condition requiring regular concomitant medication (including non-prescriptional over-the-counter (OTC) drugs), or likely to need any concomitant medication during the study. As exceptions, hormone replacement therapy in female subjects and supplementation therapy with thyroxin, iron, calcium, folate and vitamin B12 at recommended doses is allowed. Vitamin D supplementation at doses of 20 µg/day or less is also allowed. The use of other vitamins, nutritional supplements and herbal products, at recommended doses, may be allowed at the investigator's discretion. Occasional use of paracetamol for pain is allowed.
• . Use of any medication that might affect the study results or cause a health risk for the subject within 2 weeks prior to IMP administration.