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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1209 | Drug | SHR-1209,single subcutaneous injection of 450mg |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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).
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.
General situation:
Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding.
Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40587053 | Derived | Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30. | |
| 40252193 | Derived | Wang Y, Cheng Y, Guo Y, Fan Y, Zhou R, Zhang Q, Xu Y, Feng S, Shen K, Hu W. A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects. Eur J Drug Metab Pharmacokinet. 2025 May;50(3):265-272. doi: 10.1007/s13318-025-00944-5. Epub 2025 Apr 19. |
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Single-center, random, parallel, open-label
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| 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 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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