First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants

Exclusion Criteria

• •Significant history or presence of medical disorders or condition capable of significantly affecting the absorption, metabolism, or elimination of drugs
• •History or presence of psychiatric or neurologic disease or condition
• •History of seizures
• •Abnormal EEG observed at screening
• •Abnormal blood pressure
• •Breast cancer within the past 10 years, or any other malignancies within the past 5 years
• •Clinically significant abnormal results in electrocardiogram, blood and urine test
• •History or presence of liver disease
• •Participants using medication or supplements within 14 days prior to dosing
• •Use of N-methyl-D-aspartate (NMDA) receptor modulators (example: dextromethorphan, ketamine, amantadine, memantine) within 90 days of screening
• •Loss of blood or blood products in excess of 450 mL within 60 days prior to screening
• •Used any investigational drug within 60 days prior to screening
• •Recent history of alcohol or drug abuse
• •Any participant who currently uses or has used tobacco products or nicotine-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) for one month or more prior to screening
• •Significant abnormalities in lumbar spine
• •History of clinically significant back pain, back pathology, and/or back injury
• •History of migraines, and/or frequent, severe headaches
• •History or presence of significant active bleeding or coagulation disorder or use of non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion
• •Allergy to lidocaine (Xylocaine®) or related drugs
• •History of adverse reaction to lumbar puncture or epidural procedure