Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222
研究概览
简要总结
This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 5
A single subcutaneous injection of SHR-1222 dose 5 versus placebo
干预措施: SHR-1222 (Drug)
Cohort 1
A single subcutaneous injection of SHR-1222 dose 1 versus placebo
干预措施: SHR-1222 (Drug)
Cohort 1
A single subcutaneous injection of SHR-1222 dose 1 versus placebo
干预措施: Placebo (Drug)
Cohort 2
A single subcutaneous injection of SHR-1222 dose 2 versus placebo
干预措施: SHR-1222 (Drug)
Cohort 2
A single subcutaneous injection of SHR-1222 dose 2 versus placebo
干预措施: Placebo (Drug)
Cohort 3
A single subcutaneous injection of SHR-1222 dose 3 versus placebo
干预措施: SHR-1222 (Drug)
Cohort 3
A single subcutaneous injection of SHR-1222 dose 3 versus placebo
干预措施: Placebo (Drug)
Cohort 4
A single subcutaneous injection of SHR-1222 dose 4 versus placebo
干预措施: SHR-1222 (Drug)
Cohort 4
A single subcutaneous injection of SHR-1222 dose 4 versus placebo
干预措施: Placebo (Drug)
Cohort 5
A single subcutaneous injection of SHR-1222 dose 5 versus placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
PAI-1 level will be detected by ELISA.
次要结局
未报告次要终点
研究者
Zhiguang Zhou
Director, Department of Endocrinology
Second Xiangya Hospital of Central South University