MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM

Exclusion Criteria

• •1. Subjects with a personal or family history of medullary thyroid carcinoma (MTC) or in subjects with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
• •2. Screening fasting blood glucose ≤100 or ≥270 mg/dL
• •3. Type 1 diabetes mellitus, or latent autoimmune diabetes in adults; diabetic neuropathy, retinopathy or nephropathy;
• •4. Previous treatment with an approved or investigational GLP-1 mimetic;
• •5. Patients treated with any investigational drugs within 6 weeks of screening;
• •6. Subjects with pancreatitis;
• •7. Clinically significant gastrointestinal disorder
• •8. History or symptoms of clinically significant cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia,
• •9. Uncontrolled hypertension at screening;
• •10. History of clinically significant central nervous system disease including: transient ischemic attack, stroke, seizure disorder, depression,
• •11. History of liver disease
• •12. History of clinically significant renal disease
• •13. Uncontrolled severe dyslipidemia;
• •14. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• •15. A hospital admission or major surgery within 30 days prior to screening;
• •16. A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
• •17. A history of alcohol abuse according to medical history within 6 months prior to screening;
• •18. A positive screen for alcohol, or drugs of abuse;
• •19. An unwillingness or inability to comply with food and beverage restrictions during study participation;
• •20. Use of prescription or over-the-counter (OTC) medications, and herbal An
• •21. Unwillingness of male participants to use appropriate contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation. Sexual intercourse with pregnant or lactating women is prohibited