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

NCT ID: NCT06837077

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2025-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group A

Group Type: EXPERIMENTAL

SHR-1209 single-site subcutaneous injection

Intervention Type: DRUG

SHR-1209 single-site subcutaneous injection.

SHR-1209 multiple-site subcutaneous injections

Intervention Type: DRUG

SHR-1209 multiple-site subcutaneous injections.

Treatment group B

Group Type: EXPERIMENTAL

SHR-1209 single-site subcutaneous injection

Intervention Type: DRUG

SHR-1209 single-site subcutaneous injection.

SHR-1209 multiple-site subcutaneous injections

Intervention Type: DRUG

SHR-1209 multiple-site subcutaneous injections.

Interventions

SHR-1209 single-site subcutaneous injection

SHR-1209 single-site subcutaneous injection.

Intervention Type: DRUG

SHR-1209 multiple-site subcutaneous injections

SHR-1209 multiple-site subcutaneous injections.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;

2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;

3. Body mass index (BMI) at screening period must be ≥19.0 kg/m2 and <28.0 kg/m2, weight of male must≥ 50.0 kg and <90.0 kg, and female≥ 45.0 kg and <90.0 kg;

4. The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 16 weeks after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.

Exclusion Criteria

1. Serious infection within 3 months before screening;

2. History of food or drug allergy or atopic allergic disease (asthma, urticaria);

3. Positive blood pregnancy test;

4. Have a history of drug abuse;

5. Women who are pregnant or breastfeeding;

6. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Countries

China

Other Identifiers

SHR-1209-105

Identifier Type: -

Identifier Source: org_study_id