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Completed

NCT Number: NCT06501586

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SGB-3908

Drug

SGB-3908 for sc injection

SGB-3908-Matching placebo

Other

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

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: up to approximately 12 months

Secondary outcomes

  1. Change from Baseline in Blood Angiotensinogen (AGT) Level

    Time frame: up to approximately 12 months

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

    Time frame: Up to Day 3

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

    Time frame: Up to Day 3

  4. Number of Participants With Anti- SGB-3908 Antibodies

    Time frame: up to approximately 6 months

Sponsors and collaborators

Lead sponsor

Suzhou Sanegene Bio Inc.

Industry

Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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