Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
- Registration Number
- NCT03898024
- Lead Sponsor
- Second Xiangya Hospital of Central South University
- Brief Summary
This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.
- Detailed Description
In this study, total 50 patients with low bone mass will be enrolled and divided into 5 dose groups. In the lowest dose group 6 subjects will be recruited, among whom 4 will receive SHR-1222 and the other 2 will receive placebo. In each of the other 4 groups, 11 subjects will be recruited, among whom 9 will be administered with SHR-1222 and the other 2 with placebo.
Levels of nitric oxide (NO), Endothelin-1 (ET-1), plasminogen activator inhibitor-1 (PAI-1) and hypersensitivity C-reactive protein (hs-CRP) will be detected in patients before and after the SHR-1222 injection.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Signed informed consent;
- Male or postmenopausal female;
- Age ≥45 and ≤59 years old;
- The body mass index (BMI) ≥18.5kg/m2 and ≤28 kg/m2;
- T value of areal bone mineral density on any lumbar spine (L1-L4) or collum femoris>-2.5 and <-1;
- The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication;
- No smoking, alcohol or drugs abuse.
Exclusion Criteria
- Any disease affecting bone metabolism;
- Past medical history of cerebral infarction or cerebral arterial thrombosis;
- Past medical history of myocardial infarction;
- Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;
- Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;
- A bone fracture within the previous 6 months;
- A lumbar spine L1-L4 or femoral neck T-score ≤-2.5;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 1.5 x ULN during screening;
- 3 months prior to screening involved in any drug clinical subjects;
- Subjects determined by the researchers have any food, dietary supplement or drugs that affect SHR-1222 absorption, distribution, metabolism and excretion in 4 weeks prior to screening or within 5 half-lives;
- Serious infection, trauma or major surgery in 4 weeks prior to screening;
- A surgery plan during the study;
- Blood donation and transfusion in 3 months prior to screening;
- Unstable thyroid dysfunction in 6 months prior to screening;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
- Intolerant to venous blood collection;
- A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar；
- Subjects with any other situation should not be involved, which determined by the researchers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 SHR-1222 A single subcutaneous injection of SHR-1222 dose 1 versus placebo Cohort 3 Placebo A single subcutaneous injection of SHR-1222 dose 3 versus placebo Cohort 2 Placebo A single subcutaneous injection of SHR-1222 dose 2 versus placebo Cohort 5 Placebo A single subcutaneous injection of SHR-1222 dose 5 versus placebo Cohort 4 SHR-1222 A single subcutaneous injection of SHR-1222 dose 4 versus placebo Cohort 2 SHR-1222 A single subcutaneous injection of SHR-1222 dose 2 versus placebo Cohort 3 SHR-1222 A single subcutaneous injection of SHR-1222 dose 3 versus placebo Cohort 4 Placebo A single subcutaneous injection of SHR-1222 dose 4 versus placebo Cohort 1 Placebo A single subcutaneous injection of SHR-1222 dose 1 versus placebo Cohort 5 SHR-1222 A single subcutaneous injection of SHR-1222 dose 5 versus placebo
- Primary Outcome Measures
Name Time Method Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222 Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration ET-1 level will be detected by ELISA.
Assessment of serum hypersensitivity C-reactive protein (hs-CRP) change after the administration of SHR-1222 Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration hs-CRP level will be detected by immunoturbidimetry assay.
Assessment of serum nitric oxide (NO) change after the administration of SHR-1222 Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration NO level will be detected by nitrite/nitrate assay (colorimetric).
Assessment of serum plasminogen activator inhibitor-1 (PAI-1) change after the administration of SHR-1222 Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration PAI-1 level will be detected by ELISA.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China