Hypercholesterolemia and Hyperlipidemia
Conditions
Brief summary
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.
Interventions
DRUGSHR-1209
SHR-1209，single subcutaneous injection of 450mg
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Single-center, random, parallel, open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F) | Days 1-113 |
| Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax) | Days 1-113 |
| Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. | 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 |
Countries
China
Outcome results
None listed