Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass

Overview

This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 27, 2020

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.

Interventions

  • Drug: SHR-1222
    • Pharmaceutical form: water injection; Route of administration: subcutaneous
  • Drug: Placebo
    • Pharmaceutical form: water injection; Route of administration: subcutaneous

Arms, Groups and Cohorts

  • Experimental: Cohort 1
    • A single subcutaneous injection of SHR-1222 dose 1 versus placebo
  • Experimental: Cohort 2
    • A single subcutaneous injection of SHR-1222 dose 2 versus placebo
  • Experimental: Cohort 3
    • A single subcutaneous injection of SHR-1222 dose 3 versus placebo
  • Experimental: Cohort 4
    • A single subcutaneous injection of SHR-1222 dose 4 versus placebo
  • Experimental: Cohort 5
    • A single subcutaneous injection of SHR-1222 dose 5 versus placebo

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of serum nitric oxide (NO) change after the administration of SHR-1222
    • Time Frame: 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 Endothelin-1 (ET-1) change after the administration of SHR-1222
    • Time Frame: 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 plasminogen activator inhibitor-1 (PAI-1) change after the administration of SHR-1222
    • Time Frame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
    • PAI-1 level will be detected by ELISA.
  • Assessment of serum hypersensitivity C-reactive protein (hs-CRP) change after the administration of SHR-1222
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Second Xiangya Hospital of Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhiguang Zhou, Director, Department of Endocrinology – Second Xiangya Hospital of Central South University
  • Overall Official(s)
    • Zhiguang Zhou, MD, Principal Investigator, Second Xiangya Hospital of Central South University

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