NCT03944109

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

The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia - A PhaseⅠb/Ⅱ Randomized, Double-Blind, Placebo-Controlled Clinical Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	SHR-1209	Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

Timeline

• Start date: 2019-06-20
• Primary completion: 2020-12-22
• Completion: 2020-12-22
• First posted: 2019-05-09
• Last updated: 2022-11-30

Locations

1 site across 1 country: China