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

Suzhou Sanegene Bio

Status and phase

Active, not recruiting

Phase 1

Conditions

Hypertension,Essential

Treatments

Drug: SGB-3908

Other: SGB-3908-Matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06501586

SGB-3908-001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)