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The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects

Hypercholesteremia Clinical Trial

Official title:
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects

Clinical Trial Summary

This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled Phaseâ… Clinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects including assessment of immunogenicity.

Clinical Trial Description

32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03634436
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date August 30, 2018
Completion date May 28, 2019
View Details
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