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

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ClinicalTrials.gov Identifier: NCT03898024
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Zhiguang Zhou, 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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Osteopenia Drug: SHR-1222 Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density

Arm Intervention/treatment
Experimental: Cohort 1
A single subcutaneous injection of SHR-1222 dose 1 versus placebo
Drug: SHR-1222
Pharmaceutical form: water injection; Route of administration: subcutaneous

Drug: Placebo
Pharmaceutical form: water injection; Route of administration: subcutaneous

Experimental: Cohort 2
A single subcutaneous injection of SHR-1222 dose 2 versus placebo
Drug: SHR-1222
Pharmaceutical form: water injection; Route of administration: subcutaneous

Drug: Placebo
Pharmaceutical form: water injection; Route of administration: subcutaneous

Experimental: Cohort 3
A single subcutaneous injection of SHR-1222 dose 3 versus placebo
Drug: SHR-1222
Pharmaceutical form: water injection; Route of administration: subcutaneous

Drug: Placebo
Pharmaceutical form: water injection; Route of administration: subcutaneous

Experimental: Cohort 4
A single subcutaneous injection of SHR-1222 dose 4 versus placebo
Drug: SHR-1222
Pharmaceutical form: water injection; Route of administration: subcutaneous

Drug: Placebo
Pharmaceutical form: water injection; Route of administration: subcutaneous

Experimental: Cohort 5
A single subcutaneous injection of SHR-1222 dose 5 versus placebo
Drug: SHR-1222
Pharmaceutical form: water injection; Route of administration: subcutaneous

Drug: Placebo
Pharmaceutical form: water injection; Route of administration: subcutaneous




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   45 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898024


Contacts
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Contact: Zhijie Dai, MD 8613548564211 daizj09@163.com

Sponsors and Collaborators
Second Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Zhiguang Zhou, MD Second Xiangya Hospital of Central South University

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Responsible Party: Zhiguang Zhou, Director, Department of Endocrinology, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03898024     History of Changes
Other Study ID Numbers: 2019 SHR-1222
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases