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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-01-20

Brief Summary

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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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Detailed Description

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Conditions

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Hypertension,Essential

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SGB-3908

Group Type EXPERIMENTAL

SGB-3908

Intervention Type DRUG

SGB-3908 for sc injection

SGB-3908-Matching placebo

Group Type PLACEBO_COMPARATOR

SGB-3908-Matching placebo

Intervention Type OTHER

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

Interventions

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SGB-3908

SGB-3908 for sc injection

Intervention Type DRUG

SGB-3908-Matching placebo

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes