Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers

Exclusion Criteria

• •1. Are pregnant or lactating.
• •2. Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological or psychological/psychiatric disorders which, in the opinion of the Investigator, increases the risk of the study drug or may confound the interpretation of study measures.
• •3. Clinically significant abnormal findings on physical examination or vital signs as determined by Investigator.
• •4. Individuals with pacemakers, aneurysm clips, shrapnel, or other restricted implanted metallic devices will be excluded from study. All subjects complete the standard MRI screening questionnaire prior to MRI.
• •5. History or presence of psychiatric or neurological disease or condition, as determined by the Investigator.
• •6. History of seizures.
• •7. Subject with any history or current evidence of suicidal behavior.
• •8. Unwilling to complete any planned study assessments.
• •9. Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Screening.
• •10. Have received treatment with an investigational drug or device within 30 days prior to Screening.
• •11. Have a positive test for Human Immunodeficiency Virus (HIV) antibodies 1 and 2, Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV) antibody.
• •12. Any subject who is known to be allergic to the study drug or any components of the study drug.
• •13. The subject has a fasting blood glucose ≥ 126 mg/dL or hemoglobin A1c (HbA1c) ≥ 6.5% at Screening.
• •14. The subject has a history of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.
• •15. Clinically significant abnormal finding on ECG (electrocardiogram) and/or evidence of any of the following cardiac conduction abnormalities at Screening:
• •1. Heart rate \< 40 bpm and \> 100 bpm (based on the ECG reading)
• •2. QTcF interval \> 450 msec for males and females
• •3. PR interval ≥ 200 msec
• •4. Intraventricular conduction delay with QRS duration \> 120 msec
• •5. Evidence of second- or third-degree atrioventricular block (AVB)
• •6. Electrocardiographic evidence of complete left bundle branch block (LBBB), complete right bundle branch block (RBBB), or incomplete LBBB