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

NCT03898024 | Completed

• 1 other identifier: 2019 SHR-1222
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis, Osteopenia

Outcome Measures

Primary Outcomes (4)

• Assessment of serum nitric oxide (NO) change after the administration of SHR-1222

  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

  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

  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

  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

Study Arms (5)

Cohort 1

EXPERIMENTAL

A single subcutaneous injection of SHR-1222 dose 1 versus placebo

Drug: SHR-1222; Drug: Placebo

Cohort 2

EXPERIMENTAL

A single subcutaneous injection of SHR-1222 dose 2 versus placebo

Drug: SHR-1222; Drug: Placebo

Cohort 3

EXPERIMENTAL

A single subcutaneous injection of SHR-1222 dose 3 versus placebo

Drug: SHR-1222; Drug: Placebo

Cohort 4

EXPERIMENTAL

A single subcutaneous injection of SHR-1222 dose 4 versus placebo

Drug: SHR-1222; Drug: Placebo

Cohort 5

EXPERIMENTAL

A single subcutaneous injection of SHR-1222 dose 5 versus placebo

Drug: SHR-1222; Drug: Placebo

Interventions

SHR-1222 DRUG

Pharmaceutical form: water injection; Route of administration: subcutaneous

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo DRUG

Pharmaceutical form: water injection; Route of administration: subcutaneous

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zhiguang Zhou, MD

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Endocrinology

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 1, 2019
• Study Start: April 15, 2019
• Primary Completion: July 27, 2020
• Study Completion: August 15, 2020
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)