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

June 29, 2022 updated by: Zhiguang Zhou, Second Xiangya Hospital of Central South University
This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
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.
Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
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.
Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
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.
Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Xiangya Hospital of Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhiguang Zhou, MD, Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019 SHR-1222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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