Healthy volunteer
Conditions
Interventions
experimental group:Single fasting abdominal subcutaneous injection of drug candidates (LY06006, 60 mg/ 1mL, produced by Shandong Luye Pharmaceutical Co., Ltd.)
control group:Subjects have a single fasting abdominal subcutaneous injection of the reference drug (Prolia, 60 mg/1mL, manufactured by Amgen)
Sponsors
Xiangya Third Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion: 1. Subjects who signed informed consent voluntarily; 2. Healthy male subjects aged from 18 to 50 years old (including 18 and 50 years old); 3. For those subjects whose body weight is in the range of 58-68kg (including the critical value), body mass index (BMI) = weight (kg) / height 2 (M2), and body mass index is in the range of 18-28kg / m2 (excluding the critical value); 4. In the screening period, there were no abnormal or clinically significant subjects such as vital signs, physical examination, laboratory examination, 12 lead ECG, abdominal color Doppler ultrasound and chest X-ray; 5. From the screening date to the end of the study, the subjects (including their partners) had no pregnancy plan and voluntarily took effective contraceptive measures. The specific contraceptive measures are shown in Appendix 2.
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria will be excluded: 1. Patients who are suffering from or have suffered from the following diseases affecting bone metabolism: malignant tumor (including myeloma), hypoparathyroidism / hyperthyroidism, hypothyroidism / hyperthyroidism, acromegaly, Cushing's syndrome, hypopituitarism, severe chronic obstructive pulmonary disease, rheumatoid arthritis, osteomalacia, etc; 2. Patients who are suffering from or have suffered from osteomyelitis or necrosis of the mandible, or who plan to carry out invasive dental or jaw surgery during the trial, or whose wounds are not healed after dental or oral surgery; 3. Patients with fracture in the past 6 months; 4. Patients with active infection of respiratory system, digestive system, urinary system, reproductive system or skin; 5. Patients whose serum calcium is lower than or higher than the lower limit of normal value; six Patients who used drugs that may affect bone turnover before screening or during the study include but are not limited to the following drugs: desuzumab, bisphosphonates or fluoride within 12 months, estrogen containing contraceptives, tibolone, estrogen, selective estrogen receptor modulators, aromatase inhibitors, calcitonin, strontium salts, parathyroid hormone within 6 months( They were given vitamin D supplements (> 1000 IU / day), synthetic steroids, systemic glucocorticoids, calcitriol or analogues, diuretics, anticonvulsants, inhaled or topical glucocorticoids within 2 weeks; 7. Patients with allergic constitution (allergic to more than two kinds of drugs or food), or known to be allergic to the components of test drugs; 8. Those patients who donated blood or lost a lot of blood (>= 200 ml) within 3 months before screening; 9. Those who have been vaccinated within 6 months before screening or who plan to be vaccinated during the trial; 10. Subjects who took any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening; 11. The subjects who had strenuous exercise within 2 weeks before screening or planned to participate in strenuous exercise during the trial, or other factors affecting drug absorption, distribution, metabolism, excretion, etc; 12. The subjects who smoked more than 5 cigarettes per day in the first 3 months of the experiment; 13. After questioning, those who had a history of alcoholism (wine consumption over 14 units per week during the first 3 months of screening: 1 units = beer 350mL, or Baijiu 45mL or wine 150mL) or alcohol breath test positive; 14. Those with positive urine drug screening or those who have had a history of drug abuse or used drugs in the past five years after inquiry; 15. Patients with other diseases of clinical significance (such as nervous system, mental system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic endocrine system, blood system, skin diseases, immune diseases, tumor, etc.); 16. Patients with positive HBsAg, HCV-Ab, hivag / AB and Treponema pallidum antibody; 17. From the screening stage to the study medication, those subjects with acute disease or combined medication; 18. Those subjects who had taken any alcoholic products within 48 hours before the use of the test drug; 19. Those subjects who have participated in the clinical trials of desuzumab or its biological analogues in the past, who are participating in other clinical studies, or whose first adminis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pharmacokinetic parameters: the area under the plasma concentration curve from 0 to infinite time (AUC0-8); peak concentration (Cmax).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerance: vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, parathyroid hormone, etc.), 12-lead electrocardiogram, adverse events;Pharmacodynamic parameters: the rate of change of serum type I collagen C-terminal peptide (CTX) from baseline. The pharmacodynamic parameters are: AUEC0-t, Emax, TEmax;Immunogenicity: the positive rate and antibody titer of anti-drug antibody (ADA), and the positive rate of neutralizing antibody (Nab);The secondary parameters of pharmacokinetic evaluation: AUC0-t, Tmax, CL/F, ?z, t1/2z, Vz/F, etc.; | — |
Countries
China
Contacts
Public ContactYang Guoping
Xiangya Third Hospital of Central South University
Outcome results
None listed