NCT03898024

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 45 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Osteoporosis, Osteopenia

Interventions

Type	Name	Description
DRUG	SHR-1222	Pharmaceutical form: water injection; Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: water injection; Route of administration: subcutaneous

Timeline

• Start date: 2019-04-15
• Primary completion: 2020-07-27
• Completion: 2020-08-15
• First posted: 2019-04-01
• Last updated: 2022-06-30

Locations

1 site across 1 country: China