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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06501586

Enrollment

Registered

2024-07-15

Start date

2024-07-31

Completion date

2025-12-15

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

Keywords

healthy, mildly hypertensive

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.

Interventions

DRUGSGB-3908

SGB-3908 for sc injection

OTHERSGB-3908-Matching placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events (AEs)	up to approximately 12 months

Secondary

Measure	Time frame
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
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026