hypercholesterolemia
Conditions
Interventions
Experimental group:Oral experimental drug BGT-002
Control group:Oral placebo drug BGT-002
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, no gender limit; 2. Weight: male >=50 kg, female >=45 kg; Body mass index (BMI) 19-28 kg/m^2; 3. History of centerlessness, abnormal liver, kidney, digestive tract, nervous system, mental and metabolic disorders; 4. Physical examination, vital signs examination, electrocardiogram examination, laboratory examination indicators, abdominal B ultrasound are normal or within the range considered acceptable by the sponsor/investigator; 5. No parenting plan and reliable contraception during the trial period and within 6 months after the last dose; 6. Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial, sign the written informed consent, and be able to complete the whole test process according to the test requirements.
Exclusion criteria
Exclusion criteria: 1. Known allergic history, allergic disease or allergic constitution to the test preparation and any of its components or related preparations; 2. Patients with a clear medical history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc., or other diseases not suitable for clinical trials (such as psychiatric history, etc.); 3. Patients with blood donation or blood loss >= 400mL within 3 months prior to inclusion; 4. Patients who had taken any medication within 2 weeks before screening; 5. Participated in clinical trials of other drugs within 3 months before being selected; 6. Current or former drug users or those who have tested positive for drug abuse; 7. Current or past alcoholics (More than 14 standard units of alcohol per week. 1 standard unit containing 14g alcohol, such as 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or a positive breath test for alcohol; 8. Smokers who smoke more than 10 cigarettes a day; 9. Hepatitis B surface antigen (HBsAg), HCV antibody, treponema pallidum antibody and HIV antibody positive; 10. Abnormal results of chest radiographs (posterior and anterior) with clinical significance; 11. Pregnancy test positive (for women); 12. There are other factors that the researcher considers unsuitable for participating in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BGT-002 and its metabolites in plasma; | — |
Countries
China
Contacts
Public ContactYu Chen
Shanghai Xuhui Central Hospital
Outcome results
None listed