The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia

• Status: Unknown status
• Trial end date: 2020-10-01

Summary

This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects treated with stabilized dose of statin. Groups detail as follows:

1. SHR-1209 dose 1 /placebo frequence 1

2. SHR-1209 dose 2 /placebo frequence 2

3. SHR-1209 dose 3 /placebo frequence 3

4. SHR-1209 dose 4 /placebo frequence 1

5. SHR-1209 dose 5 /placebo frequence 2

6. SHR-1209 dose 6 /placebo frequence 3

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.