Evaluation of Safety, Tolerability, Pharmacokinetics, Food Effect and Interaction With Midazolam in Healthy Volunteers After Oral Single and Multiple Ascending Dosing of KAND145

1. Present or known history of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental, metabolic, endocrine, hematologic, or gastrointestinal disorder, significant respiratory disease, sleep apnea, narcolepsy or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator.

2. Any clinically significant abnormalities in physical examination, ECG (e.g., QTcF\>450 ms for males/\>460 ms for females), clinical chemistry, hematology, or urinalysis results at screening, as judged by the Investigator.

3. Clinically significant abnormal blood pressure, defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 90 mmHg at screening.

4. Pulse rate \<45 beats per minute at screening.

5. Clinically significant illness within the 5 days prior to the administration of the IMP.

6. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus.

7. Known or suspected current or history of (within the most recent 5 years) drug or alcohol abuse or positive screen for drugs of abuse test or positive alcohol breath test at screening visit or any time prior to randomization.

8. Smoking \>5 cigarettes per day (or equivalent consumption of other nicotine-containing products), or inability to refrain from smoking or using other nicotine-containing products during the stay at the study clinic.

9. Subject who has received any investigational drug within the last 3 months before administration of IMP, or who has received any dose of KAND567 in a previous clinical study.

10. Plasma donation within 1 month of the screening visit, or any blood donation/blood loss \>450 mL during the 3 months prior to the screening visit.

11. Use of the herbal remedy St. John's Wort during 2 weeks prior to administration of the IMP (induces cytochrome P450-3A4).

12. Use of prescribed medication during 2 weeks prior to the administration of the IMP (or longer if the prescribed medication has a half-life long enough to potentially expose the subject to any significant systemic exposure, as judged by the Investigator).

13. Use of over the counter drugs (including herbals) during 1 week prior to the administration of the IMP or need for concomitant medications during the study. However, use of the following may be allowed: occasional paracetamol for pain relief (up to 3 g per 24 hours), vitamin D (up to 20 μg per 24 hours), supplementation therapy with thyroxin, iron, calcium, folate, estrogen, vitamin B12, and other vitamins and minerals at recommended doses, as judged by the Investigator. Intake of preparations containing iron, calcium or other metal ions will not, however, be permitted in the 10 hours preceding and 4 hours following IMP intake. Thus, their use cannot be allowed during the treatment period of Part 2.

14. Female subjects: Positive pregnancy test at screening visit or at any time prior to dosing.

15. Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.

What this study is about