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

Phase 1

Recruiting

• Conditions: Hypertension,Essential
• Interventions: Other: SGB-3908-Matching placebo; Drug: SGB-3908

• Registration Number: NCT06501586
• Lead Sponsor: Suzhou Sanegene Bio Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-15
• Study Start: 2024-07-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-08-06
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGB-3908-Matching placebo	SGB-3908-Matching placebo	-
SGB-3908	SGB-3908	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	up to approximately 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China