Treatment of postmenopausal women with osteoporosis and treatment of solid tumor bone metastasis, prevention of bone-related events in patients with solid tumor bone metastasis
Conditions
Interventions
Arm1:a single dose of GB223
Arm2:a single dose of GB223
Arm3:a single dose of GB223
Arm4:a single dose of GB223
Arm5:a single dose of GB223
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Understand the content and steps of the trial and voluntarily sign the informed consent form; 2) Aged 18-65 years old (with border value when signing informed consent) male and female; 3) In screening period, male weight = 50kg, female weight = 45kg, male and female weight should not exceed 75kg (may be 75kg), body mass index (BMI) ranging from19.0 to 24.0 (including boundary value); 4) In screening period, physical examination, vital signs examination, laboratory examination, electrocardiogram examination, chest X-ray examination and abdominal CT examination, PPD test, oral CT examination, etc. without abnormalities or abnormalities without clinical significance; 5) The subject and partner will agree to take medically recognized effective contraceptive measures throughout the trial period and within 12 months after the study drug is administered; 6) The subjects can be followed up on a regular basis, able to communicate well with the researcher and complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1) lactating and pregnant women; 2) having a birth plan within 12 months; 3) Subjects suffering from or had osteomyelitis or mandibular necrosis, or planning to perform invasive dental or jaw surgery during the trial, or not recovered from dental or oral surgery; 4) Subjects with a clear history of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases, with a history of mental illness,a history of hypertension, or a systolic blood pressure =140 mmHg during screening, and / or diastolic blood pressure = 90 mmHg, clinically significant as judged by the investigator,a history of orthostatic hypotension; 5) Subjects with allergies, allergic to the test drug ingredients or had a history of allergies to any drug or food, or abnormal serum immunoglobulin E (IgE) test; 6) Subjects with any symptoms currently,abnormal signs or laboratory tests that may indicate acute or subacute infections (such as fever, cough, urgency, dysuria, abdominal pain, diarrhea, skin wounds, etc.); 7) Subjects with a history of drug taking or drug abuse Upon inquiry; 8)subjects smoking more than 5/day or equivalent, or no smoking during the trial; 9) Subjects drinking more than 28 units/week alcohol (1 unit = 285 ml beer or 25 ml spirits or 100ml wine),or positive for alcohol breath test within 24 hours before receiving the test drug, upon inquiry; 10) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 x ULN, serum creatinine (Cr) > 1.0 x ULN; 11) Blood routine examination: white blood cells (WBC) 9.15 × 10^9/L, neutrophils (ANC) 1000 IU/day), glucocorticoids (2 weeks before enrollment ,inhalable or topical corticosteroids can be used), anabolic hormones (such as medroxacin, phenylpropionate, oxymetholone, stanozolol, naloxazole, danazol, etc.),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Severe Adverse Event;AUC0-t;Cmax;AUC0-8;Tmax;Vz/F;Ke;t1/2z;CLz/F;MRT; | — |
Countries
China
Contacts
Public ContactHaiyan Liu
the Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed