Healthy subject
Conditions
Interventions
Experimental group:LY01011
Control group:Denosumab injection
Sponsors
Phase I Clinical Trial Laboratory, First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions; 2) Ability to complete the study as required by the protocol; 3) Subjects (including partners) have no pregnancy plans from the screening date to the end of the study and voluntarily take effective contraceptive measures. See Appendix 4 for specific contraceptive measures; 4) Healthy male or female subjects (including 18 and 50 years old) aged 18-50 years; 5) Male subjects weigh no less than 50 kg and female subjects weigh no less than 45 kg. Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index in the range of 18 ~ 28kg / m2 (including the threshold); 6) There are no abnormalities or abnormalities in the screening period of vital signs, physical examination, laboratory examination, 12-lead ECG, abdominal B-ultrasound, chest orthotopic tablets.
Exclusion criteria
Exclusion criteria: 1) those who are suffering from or have suffered from osteomyelitis or mandibular necrosis of the mandible, or who plan to perform invasive dental or jaw surgery during the trial, or who have not recovered from dental or oral surgery; 2) Fractures have occurred in the past 6 months; 3) Pre-screening or planning to use drugs that may affect bone turnover during the study, including but not limited to the following drugs: once used dizumab, bisphosphonate or fluoride in 12 months, within 6 months Estrogen-containing contraceptives, hormone replacement therapy (such as tibolone, estrogen, selective estrogen receptor modulators, etc.), aromatase inhibitors, calcitonin, strontium salts, parathyroid hormone ( Or derivatives), vitamin D supplements (>1000 IU/day), synthetic steroids, systemic glucocorticoids, calcitriol or analogues, diuretics, anticonvulsants; inhaled or topical use within 2 weeks Glucocorticoids; 4) Calcium ions are below the lower limit of normal or above the upper limit of normal; 5) Those who are allergic (allergic to two or more drugs or foods), or those who are known to be allergic to the test drug ingredients; 6) Donate blood or massive blood loss (>450mL) within 3 months before screening; 7) Those who have been vaccinated within 4 weeks prior to screening or who plan to vaccinate during the trial; 8) Take any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days prior to screening; 9) There are strenuous exercise within 2 weeks before screening, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 10) Upon inquiry, more than 5 cigarettes were smoked daily for the first 3 months of the trial; 11) Upon inquiry, there is a history of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 12) Those who are positive for urinary tract screening or who have been asked to have a history of drug abuse or drug use in the past five years; 13) Other clinically found diseases with clinical significance (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic endocrine system, blood system, skin disease, immune disease, tumor, etc.); 14) Positive detection of hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody; 15) Acute illness or concomitant medication from the screening stage to the study drug; 16) took any alcoholic products within 48 hours prior to the use of the test drug; 17) Participated in other drug clinical trials within 3 months prior to screening; 18) lactating and pregnant women; 19) The investigator believes that the exclusion is necessary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-8;CTX-1 rate of change from baseline; | — |
Countries
China
Contacts
Public ContactDing Yanhua
the First Hospital of Jilin University
Outcome results
None listed