This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Assessment of serum nitric oxide (NO) change after the administration of SHR-1222
NO level will be detected by nitrite/nitrate assay (colorimetric).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.