Evaluating SGB-3908 in Healthy and Mildly Hypertensive Individuals
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of SGB-3908 After a Single Administration in Healthy Subjects and Mildly Hypertensive Subjects
PHASE1 · Suzhou Sanegene Bio Inc. · NCT06501586
This study is testing a new drug called SGB-3908 in healthy people and those with mild high blood pressure to see how it affects their blood pressure and if it's safe to use.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Suzhou Sanegene Bio Inc. (industry) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06501586 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic effects of SGB-3908 in both healthy subjects and those with mild hypertension. It will utilize a single ascending dose (SAD) approach to determine how the drug behaves in the body and its effects on blood pressure. Participants will be monitored for any adverse reactions and changes in their health status throughout the trial. The study is designed to gather essential data that could inform future treatments for hypertension.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals or those with mildly elevated blood pressure who meet specific inclusion criteria.
Not a fit: Patients with significant underlying health conditions or recent medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for managing hypertension.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in evaluating new hypertension treatments.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Beijing, Beijing
- Peking University Third Hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Xiaolin He, Master
- Email: xiaolin_he@sanegenebio.com
- Phone: +086 18132286536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension,Essential, healthy, mildly hypertensive