Phase 1 Single Subcutaneous Dose Study of MLN1202

Exclusion Criteria

• •1. The participant has received any other investigational compound within 16 weeks (112 days) prior to administration of the study drug.
• •2. The participant has previously received agents containing MLN1202, a monoclonal antibody or monoclonal antibody fragment.
• •3. The participant has been vaccinated within 4 weeks (28 days) prior to administration of the study drug or is planning to be vaccinated during the study period.
• •4. The participant is a study site employee or immediate family member of the employee, or may consent under duress.
• •5. The participant has poorly-controlled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease, hemorrhagic disorder or other abnormalities which may impact the ability of the participant to participate or potentially confound the study results.
• •6. The participant has recurrent serious or poorly-controlled infection and is considered to have difficulty participating in the study by the investigator.
• •7. The participant has a history of hypersensitivity or allergies to MLN1202 or additives contained in MLN1202 preparations.
• •8. The participant has a history of hypersensitivity or allergies to monoclonal antibodies other than MLN1202.
• •9. The participant has positive results in urine drug tests at screening.
• •10. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol dependence within 2 years prior to the study visit at screening or is unwilling to agree to abstain from alcohol and drugs throughout the study period.
• •11. The participant requires any excluded medication or food products listed in the Excluded Medications and Dietary Products (see section 7.3) during the study period.
• •12. The participant intends to donate sperm during the study period or period until 12 weeks (84 days) after administration of the study drug.
• •13. The participant has a history of cancer.
• •14. The participant has, is suspected of having, or has a history of active tuberculosis or latent tuberculosis infection.
• •15. The participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis B virus antibody (hepatitis B surface antibody \[HBsAb\]/ hepatitis B core antibody \[HBcAb\]), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening. This does not include the participant who has a positive test result only for HBsAb due to HBV vaccination.
• •16. The participant has used nicotine-containing products (cigarettes, pipes, cigars, chewing tobacco, nicotine patches, or nicotine gum, etc.) within 4 weeks (28 days) prior to administration of the study drug.
• •17. The participant has poor peripheral venous access.
• •18. The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to administration of the study drug.
• •19. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to administration of the study drug.
• •20. The participant has undergone blood component collection within 2 weeks (14 days) prior to administration of the study drug.
• •21. The participant has any clinically significant electrocardiographic (ECG) abnormalities at the time of screening or baseline examination.
• •22. The participant has abnormal laboratory values that suggest a clinically significant underlying disease, or the participant has the following lab abnormalities at the time of screening or baseline examination: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 × the upper limits of normal, or differential white blood count (monocytes) \< the lower limit of normal.
• •The following criteria will be evaluated by laboratory tests at the screening: insulin (fasting), parathyroid hormone (PTH) (intact).
• •23. The participant has systolic blood pressure \<80 mmHg or diastolic blood pressure \<45 mmHg, or systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg at the time of screening, baseline examination or examination prior to administration of the study drug.
• •24. The participant is receiving treatment for a wound and is, in the opinion of the investigator, unsuitable to participate in the study.
• •25. The participant is scheduled to undergo surgery within 12 weeks (84 days) after administration of the study drug.
• •26. In the opinion of the investigator, the participant is unlikely to comply with the protocol or is unsuitable for any other reasons