Hypertrophic Cardiomyopathy
Conditions
Interventions
Intervention group:CMS-D003
placebo:placebo
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. Be able to communicate well with the investigator, understand and comply with the requirements and constraints of the study, and be able to complete the study in accordance with the protocol; 3. Age 18 - 45 years old (including the boundary value, subject to the day of signing the informed consent), male or female; 4. BMI within the range of 19-26 kg/m^2 (excluding boundary values) at screening, and weight > = 45.0 kg for females and >= 50.0 kg for males; 5. The acoustic window is sufficient for accurate transthoracic echocardiography; 6. Transthoracic echocardiography to examine the normal structure and function of the heart; or minor abnormalities judged by the investigator to be not clinically significant; 7. LVEF >= 65% at rest at screening and baseline; 8. Volunteers of childbearing potential have no plans to have childbearing, egg donation or sperm donation within 4 months from the date of signing the informed consent form to the last dose of the study, and must comply with the relevant regulations on contraception during this period, and must agree to take at least one highly effective non-hormonal contraceptive method.
Exclusion criteria
Exclusion criteria: 1.A history of significant multiple and/or severe allergies, including food allergies (Note: Participants with seasonal allergies may be included unless they have persistent symptoms). 2.A history of depression or post-traumatic stress disorder within 2 years prior to screening; or a history of suicidal behavior or ideation; or deemed by the investigator to be at risk for suicide (a psychiatric evaluation may be requested if necessary), which could increase the risk of participation; in the investigator’s judgment, unsuitable for participation in the study. 3.Any significant medical history or clinical manifestation of metabolic, infectious, cardiovascular, gastrointestinal, hepatic/biliary, renal/urogenital/reproductive, respiratory, endocrine, hematologic, immunologic, neurologic, dermatologic, oncologic, or psychiatric disorders requiring medication and/or other treatments (including dietary restrictions and physical therapy), as judged by the investigator to render the subject unsuitable for participation in the study. 4.Prior conditions that may affect drug absorption, including but not limited to: malabsorption syndrome, inflammatory bowel disease, partial or complete intestinal obstruction, celiac disease, gastric banding/gastrectomy, cholecystectomy, enterectomy (excluding appendectomy). 5.Received any vaccine within 4 weeks prior to screening or plans to receive a vaccine during the course of the study. 6.Used any known CYP3A or CYP2C19 inducer or inhibitor, or P-gp inhibitor within 1 month prior to dosing. 7.Used any prescription or over-the-counter medication (including herbal remedies, vitamins, minerals, and dietary supplements) within 2 weeks or at least 5 half-lives prior to dosing, whichever period is longer. 8.May require prohibited medications or treatments during the study as specified in the study protocol. 9.History of drug abuse within 6 months prior to screening and/or at screening/baseline, or a positive urine drug test at baseline. 10.History of alcohol abuse within 6 months prior to screening and/or at screening/baseline (alcohol abuse is defined as an average daily alcohol intake of more than 2 units [1 unit = 360 mL beer, 45 mL spirits with 40% alcohol content, or 150 mL wine]), or a positive breath alcohol test at baseline, or refusal to abstain from alcohol consumption and any alcohol-containing products throughout the study period. 11.Regular use of tobacco- or nicotine-containing products (including cigarettes, pipes, cigars, nicotine patches, or nicotine gum) within 6 months prior to dosing, with an average of more than 4 cigarettes per day, or refusal to avoid using such products (including e-cigarettes) throughout the study period. 12) Consump; 12.Consumption of large amounts of grapefruit (i.e., pomelo), star fruit, mango, or dragon fruit beverages or foods (e.g., grapefruit, grapefruit juice, grapefruit jam) within 14 days prior to screening; or consumption of any beverage or food containing grapefruit (i.e., pomelo), star fruit, mango, or dragon fruit within 48 hours prior to first dosing. 13.Consumption of caffeine-containing products/drugs (e.g., coffee, tea, cola beverages, other caffeinated drinks, or chocolate) within 3 days prior to dosing, or refusal to avoid such products or drugs throughout the study period. 14.Participation in strenuous exercise or physical activity within 3 days prior to dosing, or refusal to avoid strenuous exercise or physical activity throughout the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECG;TTE;Adverse event;Safety laboratory tests;vital signs;Physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| CMS-D003 PK; | — |
Countries
China
Contacts
Public ContactZhou Ying
Peking University First Hospital
Outcome results
None listed