Hypertension
Conditions
Interventions
YKYY029 Group:Single-dose YKYY029 injection (50mg 150mg 300mg 600mg 800mg), subcutaneous
Placebo Group:Single-dose Placebo injection, subcutaneous
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1)The age at the time of signing the informed consent form should be between 18 and 60 years old (including the critical value), and it should be either male or female. 2) During the screening period, the body mass index (BMI) was between 19.0 and 30.0kg/m^2 (including the critical value), and the weight was >= 50kg. 3) Healthy volunteers and patients with mild hypertension who have not received antihypertensive drug treatment at least 4 weeks before screening. 4) During screening, blood pressure must meet the following conditions: for the measurement of sitting SBP and sitting DBP in the clinic, it should be 120 mmHg < sitting SBP<=159 mmHg and 70 mmHg < sitting DBP < 100 mmHg. 5) Those with normal 12-lead electrocardiogram results or those judged by the researcher as abnormal and having no clinical significance, and whose QTcF is less than 450 ms for men and less than 470 ms for women. 6) Participants can maintain good communication with the researcher, fully understand the purpose, process, risks and other information of the trial, agree to abide by all requirements and procedures of the clinical trial, and voluntarily sign the informed consent form. 7) Fertile volunteers have no plans for giving birth, egg donation or sperm donation from the date of signing the informed consent form until the end of the trial (at least within 6 months after the study medication), and during this period, they must abide by the relevant contraceptive regulations (see Appendix 2), and must agree to adopt at least one efficient non-hormonal contraceptive method.
Exclusion criteria
Exclusion criteria: 1) History of multiple drug allergies, severe allergies, and allergies to oligonucleotide or GalNaC-containing drugs. 2) History of secondary hypertension (renal parenchymal hypertension, Cushing's syndrome, primary aldosteronism, pheochromocytoma, drug-induced hypertension, etc.). 3) Unexplained syncope and orthostatic hypotension (defined as a decrease of >= 20 mmHg in SBP or >= 10 mmHg in DBP measured in the clinic within 1 minute from supine position to upright position). 4) During the screening period or baseline period, participants whose physical examination results, vital signs, safety laboratory tests and other auxiliary tests are abnormal and are judged by the researchers as abnormal with clinical significance, or who pose unacceptable risks to participating in the research, and who meet the following laboratory indicators, should be excluded: ALT and AST are greater than 1.5 times the upper limit of the normal value. Total bilirubin > 1.5 times the upper limit of the normal value. Blood creatinine is greater than the upper limit of the normal value. Blood potassium > 5.5 mmol/L. The five items of thyroid function examination are abnormal and have clinical significance. Those who test positive for any one of the following: serum hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody (TPAb), or human immunodeficiency virus antibody (HIV-Ab). 5) Take any traditional Chinese medicine, prescription drugs, over-the-counter drugs or health supplements known to affect blood pressure within 30 days prior to randomization or during the study period. 6) Within the three months prior to screening, any other non-small nucleic acid drug trial drugs or trial devices have been received or are currently being received for treatment. 7) Have participated in any small nucleic acid drug treatment or clinical trials within 6 months prior to screening. 8) Having a history of malignant tumors within the past five years (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors. 9) It is expected that phosphodiesterase-5 inhibitors, including sildenafil, tadalafil, vardenafil and avanafil, will be used in the research process. 10) Have received a vaccine within 8 weeks before screening, or plan to receive a vaccine during the research process. 11) Metabolic diseases and cardiovascular and cerebrovascular diseases: ? A history of type II diabetes, or laboratory tests show fasting blood glucose >= 7.0 mmol/L (126 mg/dl) or glycated hemoglobin (HbA1c) >= 6.5%; ? Previous history of cardiovascular events (such as stroke, transient ischemic attack, myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention, hospitalization due to heart failure) or a clinically significant history of heart valve disease;? Other circumstances that the researcher deems may affect the conduct of the trial or increase the risk to the participants. In addition to the above, there are other significant medical histories or clinical manifestations of endocrine, cardiovascular, gastrointestinal, urinary, respiratory, hematological, immune, neurological or mental diseases, etc., requiring medication and/or other treatments, and the researcher deems them unsuitable to participate in this study. 12) A history of subcutaneous injection intolerance or significant abdominal scarring may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs and SAEs);Vital signs;Injection site reaction;Physical examination;ECG;Laboratory indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;Serum AGT;Diastolic blood pressure;Systolic blood pressure; | — |
Countries
China
Contacts
Public ContactHaiyang Li/Wanfang Wang
Peking University Third Hospital
Outcome results
None listed