Study of SGB-3908 in Healthy Subjects and Mildly Hypertensive Subjects

Launched by SUZHOU SANEGENE BIO INC. · Jul 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SGB-3908 to see how safe it is and how it affects blood pressure in both healthy individuals and those with mild high blood pressure, also known as hypertension. The research is taking place in the early phase of testing, where participants will receive a single dose of the medication. The goal is to understand how the body processes the drug and how it may help control blood pressure levels.

To participate in this trial, individuals need to be between the ages of 18 and 65, have a body weight of at least 50 kilograms, and have specific blood pressure readings that fall within certain ranges. Participants can expect to undergo health screenings to ensure they are eligible, and they will be monitored closely during the study for any side effects or changes in their health. It's important to note that people with certain medical conditions, such as serious liver or kidney disease, or those who have had significant health issues recently, may not qualify for the trial. Overall, this study aims to gather important information about SGB-3908, which could potentially lead to better treatments for high blood pressure in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has body mass index (BMI) ≥18 and ≤30 kg/m\^2 and has bodyweight ≥ 50 kg;
• • Has Systolic blood pressure (SBP) ≥100 mmHg and ≤150 mmHg and diastolic blood pressure (DBP) ≥65 mmHg and ≤95 mmHg at screening;
• Exclusion Criteria:
• • Has mental illness, liver and kidney disease, gastrointestinal disease, nervous system disease, or other related systemic diseases that affect the trial;
• • Has a history of hospitalization or other clinically significant diseases within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator;
• • Has a history of orthostatic hypotension or syncope;
• * Patients with clinically significant abnormalities confirmed by physical examination, 12-lead electrocardiogram, laboratory tests, etc., or those who meet any of the following conditions during screening need to be excluded:
• • 1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin higher than 1.5× upper limit of normal (ULN)
• • 2. Serum creatinine (Cr) higher than ULN
• • 3. Serum potassium higher than 5 mmol/L
• • 4. QT/QTc interval prolongation during screening (QTcF\>450 ms)