Hypertension
Conditions
Interventions
Experimental group:HJY-ATRQß-001 injection
Sponsors
Union hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 45 years, male or female, with a body mass index (BMI) of 19 to 26 kg/m^2(body weight not exceeding 80 kg; minimum body weight of 50 kg for male subjects and 45 kg for female subjects). 2. Subjects with normal blood pressure: systolic blood pressure (SBP) >90 mmHg and 60 mmHg and <90 mmHg at screening. 3. Contraception requirements: Subjects (including their partners) must be willing to voluntarily use effective contraceptive measures from screening through 6 months after the last dose of study drug, with no plan or desire for pregnancy, and no plan to donate sperm or ova. Subjects must agree to use effective contraception during the study. Female subjects of childbearing potential must have a negative serum pregnancy test. 4. Subjects must understand and comply with the study procedures, participate voluntarily, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects with any of the following diseases or conditions will be excluded: 1. Subjects with a history of special allergies: subjects with allergic constitution, including hypersensitivity to multiple drugs and foods, any component of the study vaccine, or drugs and protein preparations. 2. Subjects with any clinically significant abnormalities in physical examination, electrocardiogram, or clinical laboratory results. 3. Subjects with any of the following diseases or conditions will be excluded: history of cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, or metabolic disorders, such as hypertension, diabetes, hyperlipidemia (total cholesterol >6.9 mmol/L, triglycerides >3.5 mmol/L), hepatic dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3× upper limit of normal], renal insufficiency [estimated glomerular filtration rate (eGFR) 14 standard units of alcohol per week; 1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), or subjects with a positive alcohol breath test. 5. Heavy smokers: subjects who smoked >5 cigarettes per day within 14 days prior to screening, or subjects who cannot abstain from using any tobacco products during the trial period. 6. Drug users: subjects with current or past drug use, or subjects with a positive drug abuse screening test. 7. Subjects with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and/or human immunodeficiency virus (HIV) antibody, or toluidine red unheated serum test (TRUST) for syphilis. 8. Subjects who have taken any medication within two weeks prior to screening; subjects who have undergone major surgical procedures within 6 months prior to the trial, or subjects who plan to undergo surgery during the study period. 9. History of blood donation: subjects who have donated blood or experienced massive blood loss (>=400 mL) within 3 months prior to screening. 10. Subjects with difficulty in blood collection, such as those who cannot tolerate venipuncture, or those with a history of syncope due to needle insertion or blood exposure. 11. Subjects whom the Investigator considers to have other factors rendering them unsuitable for participation in this trial (for special circumstances). 12. Subjects who have participated in a drug clinical trial or a clinical trial of a Qß vector-based vaccine within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Incidence and severity of serious adverse events (SAEs);Abnormalities in safety assessments; | — |
Countries
China
Contacts
Public ContactXiang Cheng
Union hospital of Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed