Reduces the risk of cardiovascular (CV) death, myocardial infarction (MI), stroke, and non-selective coronary revascularization in adult patients diagnosed with atherosclerotic cardiovascular disease (ASCVD)
Conditions
Interventions
Group 1:Obicetrapib dose 5 mg
Group 2:Obicetrapib dose 10 mg
Group 3:Obicetrapib dose 25 mg
Group 4:Obicetrapib dose 10 mg
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese male or female subjects aged >= 18 years old and = 50.0 kg, female body weight >= 45.0 kg, and body mass index (BMI) >= 19.0 kg/m2 and < 27.0 kg/m2; 3. Subjects are in good health (normal or abnormal without clinical significance) as determined by past medical history, physical examination, vital signs, electrocardiogram, and local laboratory tests at the Screening and Baseline Visit; 4. Able to communicate well with the investigator, and to understand and comply with the study procedures; 5. Give informed consent to the study and voluntarily sign the informed consent form prior to any trial-related activities.
Exclusion criteria
Exclusion criteria: 1. Previously or currently suffering from endocrine, thyroid, liver, respiratory or renal function impairment, diabetes, coronary heart disease or any history of mental disease, and the researchers believe that the abnormality has clinical significance; 2. Family history of long QT syndrome, hypokalemia or torsade de pointes; 3. Patients with acute upper respiratory tract infection or other acute infections within 2 weeks; 4. Currently accompanied or previously suffering from any gastrointestinal, liver, kidney disease or other pathophysiological conditions, which are judged to interfere with drug absorption, distribution, metabolism or excretion; 5. Allergic constitution, or severe allergic reaction to any drug or allergic to the test drug and its excipients; 6. Use prescription drugs 4 weeks before administration or use non-prescription drugs 1 week before administration; 7. Those who have received Obicetrapib treatment before; 8. ECG QTcF >= 450 ms during screening period or baseline period; 9. Blood pressure (lying position) during the screening period and D-1 (baseline period) is outside the range of 90-139 mmHg (systolic blood pressure, including boundary values) and 50-89mmHg (diastolic blood pressure, including boundary values); or pulse rate (lying bit) outside the range of 50-100 beats/min (including boundary value); or ear temperature > 37.5°C; 10. Subjects were positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and Treponema pallidum specific antibody (TPPA) during the screening period; 11. Have a history of drug abuse or have a positive urine test for drug abuse during the screening period or D-1 (baseline period); 12. Participated in other clinical trials and received treatment with other experimental drugs or devices within 3 months before screening. If the 5 half-lives of the experimental drugs exceed 3 months, the longer time is the limit; 13. Positive smoke test during the screening period or had smoked within three months before screening; 14. Have a history of alcoholism or drink more than 21 units per week (1 unit = 280 mL of beer, 25 mL of spirits or 125 mL of wine), or have a positive alcohol breath test during the screening period; 15. Consumption of food or beverages containing grapefruit, cranberry, dietary supplements or herbal medicine within 7 days before administration; 16. Subjects consumed excessive caffeine, cola or tea within 3 days before administration; 17. Donate blood within 3 months before screening, or plan to donate blood or blood components within 1 month after the last visit; 18. Pregnant or lactating women, or subjects who cannot take effective contraceptive measures or family planning during the trial and within 3 months after the trial; 19. The investigator believes that the subject has other conditions that are not suitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK after single administration;PK after multiple administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| PD after single administration;PD after multiple administration;Adverse event;Vital signs;Physical examination;Laboratory examination;12-lead ECG; | — |
Countries
China
Contacts
Public ContactZhang Jing
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed