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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypercholesterolemia and Hyperlipidemia
• Intervention / Treatment: Drug: SHR-1209 single-site subcutaneous injection; Drug: SHR-1209 multiple-site subcutaneous injections

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The First Affiliated hospital of USTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	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.
Experimental: Treatment group B	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.	After injection in day 1 and day 57.
Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209.	After injections in day 1 and day 57.
Area under the curve (AUC0-56).	After injection in day 1 up to day 56.
Peak time (Tmax) of SHR-1209.	After injection in day 1 up to day 56.
Peak concentration (Cmax) of SHR-1209.	After injection in day 1 up to day 56.

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjects' preferred method of SHR-1209 administration between the tested injection regimens.	Day 68.
Incidence and severity of adverse events (AEs).	From Day 1 to Day 169.
Incidence and severity of serious adverse events (SAEs).	From Day 1 to Day 169.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: SHR-1209-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No