Status:
ACTIVE_NOT_RECRUITING
Study of SGB-3908 in Healthy Subjects and Mildly Hypertensive Subjects
Lead Sponsor:
Suzhou Sanegene Bio Inc.
Collaborating Sponsors:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hypertension,Essential
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3908 in healthy subjects and mildly hypertensive subjects. The study wi...
Eligibility Criteria
Inclusion
- 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
- 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:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin higher than 1.5× upper limit of normal (ULN)
- Serum creatinine (Cr) higher than ULN
- Serum potassium higher than 5 mmol/L
- QT/QTc interval prolongation during screening (QTcF\>450 ms)
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06501586
Start Date
July 31 2024
End Date
January 20 2026
Last Update
September 30 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100083