About this trial
This is a first-in-human study to evaluate the safety, tolerability, PK, and PD characteristics of SYH2072 Tablets after single and multiple oral doses in healthy participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants must be fully informed about the study content, procedures, and potential adverse reactions, and voluntarily sign the written informed consent form (ICF) before the study;
Sex: Male or female;
Age: 18-55 years old (inclusive);
Body mass index in the range of 19 to 30 kg•m-2 [Body Mass Index (BMI) = weight/height2 (kg•m²)] (inclusive), with a body weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);
Disqualifiers
History of severe allergic diseases or allergic constitution (allergy to ≥ 3 drugs or foods);
Use of corticosteroid drugs within 3 months prior to screening;
Past and/or current clinically significant medical conditions, including but not limited to diseases of the circulatory, hematologic or hematopoietic, respiratory, endocrine, urinary, digestive, nervous or psychiatric systems, infections, tumors, severe trauma, or any other disease that the investigator considers should be excluded or may interfere with the interpretation of the study results;
Postural tachycardia (heart rate increase > 30 beats/minute upon standing) or postural hypotension (decrease in SBP ≥ 20mmHg or DBP ≥ 10mmHg upon standing) at screening;
Trial design
Parallel
Treatments tested in this trial
SYH2072 Tablets
DrugSYH2072 tablets will be administered as a single or multiple oral doses.
SYH2072 Placebo
DrugSYH2072 placebo tablets will be administered as a single or multiple oral doses.
Treatment groups
Trial outcomes
Primary outcomes
The rate of Adverse events
The rate of Adverse events occur during the whole study
The rate of normality or abnormality of electrocardiogram
The rate of normality or abnormality of electrocardiogram during the whole study
Sponsors and contacts
Click on the lead sponsor to view all of their trials.