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

NCT06501586 | Completed Phase 1

• 1 other identifier: SGB-3908-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension,Essential

Keywords

healthy; mildly hypertensive

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  up to approximately 12 months

Secondary Outcomes (4)

• Change from Baseline in Blood Angiotensinogen (AGT) Level

  up to approximately 12 months

• Maximum Observed Plasma Concentration (Cmax) of SGB-3908 and of Potential Metabolites

  Up to Day 3

• Area Under the Concentration-time Curve (AUC) of SGB-3908 and of Potential Metabolites

  Up to Day 3

• Number of Participants With Anti- SGB-3908 Antibodies

  up to approximately 6 months

Study Arms (2)

SGB-3908

EXPERIMENTAL

Drug: SGB-3908

SGB-3908-Matching placebo

PLACEBO COMPARATOR

Other: SGB-3908-Matching placebo

Interventions

SGB-3908-Matching placebo OTHER

Normal saline (0.9% NaCl) matching volume of SGB-3908 doses will be administered

SGB-3908-Matching placebo

SGB-3908 DRUG

SGB-3908 for sc injection

SGB-3908

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Suzhou Sanegene Bio Inc.: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: July 31, 2024
• Primary Completion: April 7, 2025
• Study Completion: December 15, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CN (1)