Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects

Exclusion Criteria

• •History of allergic responses to Abatacept or other related drugs, or any of its formulation ingredients.
• •2\) Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• •3\) History or presence of chronic obstructive pulmonary disease (COPD). 4) Use of any hormone replacement therapy within 3 months prior to the study medication administration.
• •5\) Use of any depot injection or implant of any drug within 3 months prior to the study medication administration.
• •6\) Use of CYP enzyme inhibitors or inducers within 30 days prior to the study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• •7\) History or evidence of drug dependence. 8) Reports smoking or using tobacco products or is currently using nicotine products (cigarettes, patches, gums, etc.) 14 days prior to screening.
• •9\) Reports history of drug or alcohol addiction or abuse within the past 1 year.
• •10\) History of difficulty with donating blood or difficulty in accessibility of veins.
• •11\) A positive hepatitis screen (hepatitis B surface antigen, hepatitis C antibody).
• •12\) A positive test result for HIV antibody. 13) A positive QuantiFERON®-TB Gold Plus (Tuberculosis) test. 14) Volunteers who have received a known investigational drug within seven elimination half-lives of the administered drug prior to the study medication administration.
• •15\) Reports a blood donation totaling between 101 mL to 499 mL within 30 days prior to study drug administration or a blood donation of more than 499 mL within 56 days prior study drug administration for male volunteers and 84 days prior to study drug administration for female volunteers. All volunteers will be advised not to donate blood for 30 days after completing the study.
• •16\) Intolerance to venipuncture 17) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
• •18\) Institutionalized volunteers. 19) Use of any prescribed medications within 14 days prior to the study medication administration.
• •20\) Use of any OTC products, vitamin and herbal products, etc., within 14 days prior to the study medication administration.
• •21\) Use of grapefruit and grapefruit containing products within 7 days prior to the study medication administration.
• •22\) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for 48 hours prior to administration of study drug, recreational drugs within 30 days prior to screening.
• •23\) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the study medication administration.
• •24\) History of anaphylactic shock. 25) Subjects with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
• •26\) Subject has received any live vaccine within one month preceding study drug administration or not able to avoid live vaccines until three months after dosing.