NCT06837077

Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers

A Single-center, Randomized, Crossover, Open-label Phase I Study to Compare the Safety and Pharmacokinetics of SHR-1209 Given as Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.

Conditions

• Hypercholesterolemia and Hyperlipidemia

Interventions

Type	Name	Description
DRUG	SHR-1209 single-site subcutaneous injection	SHR-1209 single-site subcutaneous injection.
DRUG	SHR-1209 multiple-site subcutaneous injections	SHR-1209 multiple-site subcutaneous injections.

Timeline

• Start date: 2025-03-14
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2025-02-20
• Last updated: 2025-06-24

Locations

1 site across 1 country: China