Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
NCT06837077 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2025-06-24
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
- 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.
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-14
- Primary Completion
- 2025-06-30
- Completion
- 2025-07-31
Countries
- China
Study Locations
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