PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases

Exclusion Criteria

• •1. Previous occurrence or concomitant osteomyelitis of the jaw or osteonecrosis of the jaw, dental disease or jaw disease that is active, requiring oral surgery, dental surgery or oral surgery wound that has not fully healed, or has planned invasive dental procedures during the study;
• •2. History of major joint trauma or surgery within 1 year prior to enrollment
• •3. Cardiac dysfunction Within 6 months before enrollment;
• •4. Resting tachycardia or resting bradycardia on ECG at screening；
• •5. Subjects who have evidence of orthostatic hypotension at screening；
• •6. Hepatitis B surface antigen (HBSAG), hepatitis C antibody (HCVAB), human immune defect antivirus (HIV) antibody, syphilis antibody;
• •7. The pain of the subjects not predominantly related to a bone metastasis;
• •8. The subject with neurological diseases and/or mental illness and/or cognitive dysfunction ；
• •9. Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 1 month of the treatment period, and the subject who received the radiotherapy within one month before the first research drug administration
• •10. Subject has a history of allergic or anaphylactic reaction to mammalian -based drugs, or allergies to supplements (calcium or vitamin D supplements), or have a history of allergens of opioids, or past history of treatment or diagnostic monoclonal antibody, Or other allergies;
• •11. The subject participated in the treatment of other clinical trials within one month before receiving the experimental drug (except for participating in other clinical trial screening losers);
• •12. In the judgment of the investigator, would make the subject inappropriate for entry into this study;