Hypertrophic cardiomyopathy
Conditions
Interventions
SAD stage CMS-D003 group:Six dose groups (3 mg, 10 mg, 20 mg, 30 mg, 40 mg and 50 mg) were taken orally on an empty stomach.
SAD stage placebo group:Six dose groups (3 mg, 10 mg, 20 mg, 30 mg, 40 mg and 50 mg) were taken orally on an empty stomach.
MAD stage CMS-D003 group:Three dose groups (10 mg, 20 mg and 30 mg) were taken orally on an empty stomach.
MAD stage placebo group:Three dose groups (10 mg, 20 mg and 30 mg) were taken orally on an empty stomach.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Volunteer to participate in this study and sign the informed consent form; 2) Be able to communicate well with the researchers, understand and comply with the requirements and restrictions of this study, and be able to complete the study in accordance with the protocol; 3) Age 18-45 years old (including the boundary value, based on the day of signing the informed consent form), male or female; 4) BMI is within the range of 19-26 kg/m^2 (excluding the boundary value) at screening, and the weight of women is >= 45.0 kg, and the weight of men is >=50.0 kg; 5) The acoustic window is sufficient for accurate transthoracic echocardiography; 6) Transthoracic echocardiography shows normal cardiac structure and function; or the researchers judge that minor abnormalities have no clinical significance; 7) LVEF >= 65% at rest during screening and baseline; 8) Volunteers with fertility have no plans to give birth, donate eggs or donate sperm within 4 months from the date of signing the informed consent form to the last medication 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, etc.
Exclusion criteria
Exclusion criteria: 1) Have a clear history of multiple and/or severe allergies, including food allergies (Note: Those with seasonal allergies are allowed to participate, except those with persistent symptoms). 2) Have a history of depression or post-traumatic stress disorder within 2 years before screening; or have suicidal behavior or suicidal tendencies; or have suicidal tendencies as determined by the researcher (psychiatrists may be asked to conduct assessments if necessary), which may increase the risk of participating in the study and are not suitable for participation in the study according to the researcher's judgment; 3) Have any important history or clinical manifestations of metabolic, infectious, cardiovascular, gastrointestinal, liver/biliary, kidney/urinary/reproductive, respiratory, endocrine, hematological, immune, neurological, skin, malignant tumors or mental illnesses, require medication and/or other treatments (including dietary restrictions and physical therapy), and the researcher believes that they are not suitable for participating in this study; 4) Have any previous 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, intestinal resection (except appendectomy); 5) Vaccinated within 4 weeks before screening or plan to be vaccinated during the study; 6) Use of drugs or substances known to be CYP3A or CYP2C19 inducers or inhibitors, or P-gp inhibitors within 1 month before administration; 7) Use of any prescription or over-the-counter drugs (including Chinese herbal medicines, vitamins, minerals, and dietary supplements, etc.) within 2 weeks or at least 5 half-lives before administration, whichever is longer; 8) May need to receive prohibited drugs or treatments specified in this study during the study; 9) History of drug abuse within 6 months before screening and/or screening, or positive urine drug test at baseline; 10) History of alcoholism within 6 months before screening and/or screening, or baseline (alcoholism refers to an average daily drinking of > 2 units of alcohol [1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine]), or positive alcohol breath test at baseline, or refusal to stop drinking or consuming any alcoholic products during the entire study; 11) Frequent use of tobacco or nicotine-containing products (including cigarettes, pipes, cigars, nicotine patches or nicotine gum) within 6 months before administration, with an average daily smoking of > 4 cigarettes, or refusal to avoid using tobacco or nicotine-containing products (including e-cigarettes) throughout the study period; 12) Those who consumed a large amount of beverages or foods rich in grapefruit (i.e. grapefruit), carambolas, mangoes, and pitaya (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; or those who consumed any beverage or food containing grapefruit (i.e. grapefruit), carambolas, mangoes, and pitaya within 48 hours before the first administration; 13) Those who consumed caffeinated products/drugs (such as coffee, tea, cola drinks, other caffeinated beverages or chocolate, etc.) within 3 days before administration, or refused to avoid such products or drugs throughout the study period; 14) Those who performed strenuous exercise or physical activity within 3 days before administration, or refused to avoid stre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Safety laboratory tests;12-lead ECG;Transthoracic echocardiography;Vital signs;Physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of CMS-D003; | — |
Countries
China
Contacts
Public ContactLi Jianping, Zhou Ying
Peking University First Hospital
Outcome results
None listed