Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers

A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers

In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites for administration.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia and Hyperlipidemia
• Intervention / Treatment: Drug: SHR-1209

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 ≥18.5 kg/m2 and <30.0 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 2 weeks before screening to 6 months after the administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.

Exclusion Criteria:

1. History of the following diseases or treatments:

   Diseases that affect drug absorption, distribution, metabolism, and excretion determined by the investigator; Serious infection within 3 months before screening; History of drug allergy or atopic allergic disease (asthma, urticaria).

2. Any one of the following tests at Screening period or Baseline period:

   Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; Positive blood pregnancy test.

3. General situation:

   Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding.

4. 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: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: SHR-1209; SHR-1209，single subcutaneous injection of 450mg
Experimental: Treatment group B	Drug: SHR-1209; SHR-1209，single subcutaneous injection of 450mg
Experimental: Treatment group C	Drug: SHR-1209; SHR-1209，single subcutaneous injection of 450mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t)	Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞)	Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax)	Days 1-113

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax)	Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2)	Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F)	Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F)	Days 1-113
Incidence and severity of adverse events (AE), serious adverse events (SAE), etc.	Days 1-113

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 7, 2022
• First Submitted That Met QC Criteria: May 7, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: SHR-1209-104

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