NCT06501586
Completed
Phase 1
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
Suzhou Sanegene Bio Inc.1 site in 1 country40 target enrollmentJuly 31, 2024
ConditionsHypertension,Essential
Overview
- Phase
- Phase 1
- Intervention
- SGB-3908
- Conditions
- Hypertension,Essential
- Sponsor
- Suzhou Sanegene Bio Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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 will be a single ascending dose (SAD) phase.
Investigators
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:
- •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)
Arms & Interventions
SGB-3908
Intervention: SGB-3908
SGB-3908-Matching placebo
Intervention: SGB-3908-Matching placebo
Outcomes
Primary Outcomes
Number of Participants with Adverse Events (AEs)
Time Frame: up to approximately 12 months
Secondary Outcomes
- Maximum Observed Plasma Concentration (Cmax) of SGB-3908 and of Potential Metabolites(Up to Day 3)
- Number of Participants With Anti- SGB-3908 Antibodies(up to approximately 6 months)
- Change from Baseline in Blood Angiotensinogen (AGT) Level(up to approximately 12 months)
- Area Under the Concentration-time Curve (AUC) of SGB-3908 and of Potential Metabolites(Up to Day 3)
Study Sites (1)
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