Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

Exclusion Criteria

• •The subjects will be excluded from the study based on the following criteria:
• •1. Known hypersensitivity to Denosumab or to any of the components of the study drug
• •2. Participating or has received any investigational drug (or is currently using an investigational device) within 30 days before receiving the study drug, or at least 10 times the respective elimination halflife (whichever period is longer) \*
• •3. A serious infection (associated with housing and/or required intravenous anti-infectives) within 6 months before study drug administration and/or any active infection within 4 weeks of screening requiring oral or systemic antibiotics
• •4. History of significant drug abuse within 12 months before screening or a use of soft drugs (such as marijuana) within 3 months before the screening visit or hard drugs (such as cocaine, phencyclidine, and crack etc.) within 12 months before screening
• •5. Smokers who smoke ≥ 10 cigarettes or equivalent per day within 90 days prior to screening
• •6. Subjects with positive urine screen for drugs of abuse at the time of screening or check-in
• •7. Subjects with Urine Cotinine \> 500ng/ml at the time of screening or check-in
• •8. Subjects with risk of osteonecrosis of the jaw i.e. poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease or have undergone invasive dental procedures e.g. tooth extractions within last 6 months prior to screening.
• •9. Subjects with a predictable risk of invasive dental surgery during the 9 months after dosing or with planned invasive dental procedure
• •10. Subjects with known bone disease or recent fracture or abnormalities of calcium metabolism
• •11. Loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days before dosing
• •12. History of immunodeficiency (including those subjects with a positive test for human immunodeficiency virus \[HIV\] at screening)
• •13. Have a positive result for hepatitis B antigen test (HBsAg) or hepatitis C antibody test (HCAb), or show evidence of possible infection
• •14. Major surgical procedure within 28 days of dose of investigational product.
• •15. Male subjects having pregnant female partner at the time of screening.
• •16. Subject with a history of recurrent or chronic infections
• •17. Received live vaccines within 4 weeks or who may require live vaccine(s) during the study duration
• •18. Prior use of denosumab
• •19. Have previously been exposed to a monoclonal antibody or fusion protein within 270 days (other than denosumab) prior to randomisation and/or there is confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
• •20. Any reason/condition which would preclude subject's participation in the study as per the Investigator's opinion or warnings and contraindications in the prescribing information of Prolia
• •21. Subjects with suspected signs and symptoms of COVID-19/confirmed novel coronavirus infection (COVID-19).