None listed
Conditions
Interventions
Experimental group:CMAB807X 120mg single subcutaneous injections
Control group:Angarvir 120mg single subcutaneous injections
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects aged at least 18 years old and under 45 years (including the boundary value) on the date of signing the informed consent; 2. The body weight should be 58.0~68.0kg (including the critical value), and the body mass index (BMI) should be between 18.0~28.0kg/m^2 (including the boundary value); 3. The subject agrees to use medically approved effective contraception (including physical contraception, surgical contraception, abstinence, etc.) throughout the study period until at least 6 months after administration; 4. The subject has the ability to understand the full features and purpose of the study, including the possible risks and side effects of the study; And be able to communicate well with researchers and complete research according to research regulations; 5. Subjects must give informed consent to this study prior to the study and voluntarily sign a written informed consent (name and time).
Exclusion criteria
Exclusion criteria: 1. Any abnormality in medical examination (vital signs, physical examination, electrocardiogram, chest X-ray, cervical and abdominal B-ultrasound, and laboratory examination including blood routine, urine routine, blood biochemistry, etc.) which is judged by researchers to be clinically significant; 2. Serum calcium level is beyond the normal range; 3. 12-lead ECG QTcF>450 ms; 4. Known dermatitis or abnormal skin symptoms in and around the administration site; 5. Those who have had, but are not limited to, critical diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, urinary system, digestive system, respiratory system, metabolism and bone, or currently have any disease or active infection with any of the above systems, or any other disease or physiological condition that may interfere with the test results, such as hereditary bleeding propensity or coagulation disorder, or a history of thrombosis or bleeding; 6. Previous diagnosis of bone diseases that investigators have judged to be clinically significant, or any disease that affects bone metabolism, including but not limited to: Malignant tumors (including myeloma), hypothyroidism/hyperthyroidism, hypoparathyroidism/hyperthyroidism, acromegaly, Cushing's syndrome, hypopituitarism, severe chronic obstructive pulmonary disease, rheumatoid arthritis, osteomalacia, etc.; 7. Past or existing osteomyelitis or necrosis of the jaw (ONJ), or risk factors for ONJ, such as invasive dental surgery or jaw surgery during the trial, or unhealed dental or oral surgery wounds; 8. Fractures occurred within 6 months before signing the informed consent; 9. Patients who have received surgical procedures within 3 months before signing the informed consent, or who plan to have surgical procedures during the study period; 10. Allergic to two or more drugs or foods, or to any component of the investigational medicinal product; 11. Use of any prescription drug, over-the-counter drug, vitamin product or Chinese herbal medicine within 30 days prior to signing the informed consent, or prior use of the drug within 5 half-lives, whichever is the older; 12. Prior to administration, use of any medications that may affect bone metabolism (e.g., bisphosphonate or fluoride, estrogen, selective estrogen receptor modulators, calcitonin, parathyroid hormone, high dose vitamin D (>1000 IU/ day), anabolic steroids, systemic glucocorticoids, within 12 months, Or use calcitriol within 6 months); 13. Use of anti-RANKL mab in the 12 months before signing the informed consent, or use of any biological agent in the previous 3 months; 14. Those who received the vaccine within 4 weeks prior to signing the informed consent or plan to receive the vaccine during the study period; 15. Patients with a history of drug abuse or who have tested positive for urine drugs; 16. Blood donation or massive blood loss (>=200 mL) within 3 months before signing the informed consent, or planned blood donors during the study period; 17. Patients who cannot tolerate venipunction and have a history of fainting needle and fainting blood; 18. Enrolled in other drug or device clinical trials within 3 months before signing the informed consent; 19. Smokers who smoked more than 5 cigarettes per day in the 6 months before signing the informed consent, or who could not stop using any tobacco products during the test period; 20. Consuming more than 14 units of alcohol per week (1 unit = 17.7mL etha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration;Area under the plasma concentration-time curve from zero time to inferred infinite time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The area under the plasma concentration-time curve from zero time to the last measured concentration;Time to peak plasma concentration;Half-life, t1/2;Clearance rate;Apparent volume of distribution;Pharmacodynamics: CTX1;Immunogenicity: ADA;Immunogenicity: Nab;Adverse events; | — |
Countries
China
Contacts
Public ContactHu Wei
Drug Clinical Trial Research Center, the Second Hospital of Anhui Medical University
Outcome results
None listed