Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial. The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are to assess the clinical safety and immnogenicity similarity of single and subcutaneous injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the pharmacodynamic similarities of CMAB807 and Prolia®.

Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection.

Inclusion criteria

• Fully understand and voluntary sign the informed consent form,and be able to complete the study according to the protocol;
• 18 years ≤ age ≤65 years;
• Physical examination, vital signs, clinical laboratory examination and various examinations are normal or abnormal without clinical significance;
• Agree to take effective contraceptive measures throughout the study period (including not limited to: physical contraception, hormonal drugs of pregnancy, surgery, abstinence, etc.,) until at least 10 months after the last study is administered;
• Body weight ≥50 kg, 19kg/m2≤BMI≤26kg/m2;
• Serum calcium level between 2.15~2.55mmol/L（including the boundary value）;
• Normal or clinically acceptable electrocardiogram (12-lead ECG), QTcB<450msec.

Exclusion criteria

• Drink 14 units of alcohol per week within 3 months prior to administration, or take any alcohol substance within 48 hours before subcutaneous injection;
• Substance abuse within 5 years before subcutaneous injection;
• Smoke more than 5 cigarettes per day or the same amount of tobacco within 3 months before subcutaneous injection;
• Allergic constitution;
• Drink excessive amounts of tea, coffee or caffeinated beverages within 30 days before subcutaneous injection;
• Use any prescription, over-the-counter, vitamin or herbal medicine within 30 days before subcutaneous injection;
• Bone surgery was performed within 30 days before administration;
• History of osteomyelitis or osteonecrosis of the jaw;
• Inflammation or abnormalities in or around the site of administration;
• Needle or blood sickness;
• Dental disease or jaw disease requiring oral surgery, dental surgery; or plan to have dental surgery during the study;
• Received the study drug(including Xgeva and Prolia), or participated in a clinical trial within 3 months prior to administration；
• Received living viraL vaccine within 3 months prior to administration;
• Blood donation or blood loss >400ml within 3 months prior to administration;
• Hepatitis B surface antigen was positive, and/or hepatitis C antibody was positive;
• The HIV antibody test was not negative;
• Syphilitic test was positive;
• Drug was detected in the urine;
• Hyperparathyroidism, hypothyroidism, rheumatoid arthritis, Ankylosing Spondylitis, osteomalacia, Paget's disease, or fracture within 6 months;
• History of severe lumbar disc herniation;
• Insanity or legal problem are exist;
• Plan to engage in strenuous physical labor or exercise during the study;
• Other conditions that made it difficult to participate the study.