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| Name | Class |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGB-3908 | Experimental |
| |
| SGB-3908-Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGB-3908 | Drug | SGB-3908 for sc injection |
| |
| SGB-3908-Matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100083 | China |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Other |
Normal saline (0.9% NaCl) matching volume of SGB-3908 doses will be administered |
|
| 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 |