Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of SYH2062 injection in healthy Chinese volunteers
A Phase 1, randomized, double-Blind, placebo-Controlled study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SYH2062 injection after a single administration in healthy subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2062 injection | Experimental |
| |
| SYH2062-Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2062 injection | Drug | SYH2062 for sc injection |
| |
| 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 | |
| Change from Baseline in in plasma renin concentration | up to approximately 12 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Allergic constitution, or known history of allergy to the components of the study drug or similar drugs.
2 Subjects with the following diseases of clinical significance (including but not limited to diseases of the circulatory system, diseases of the blood or hematopoietic system, diseases of the respiratory system, diseases of the endocrine system, diseases of the urinary system, diseases of the digestive system, neurological or mental diseases, infections, tumors, serious injuries).
3 Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
4 Blood loss or blood donation of more than 200 mL within 3 months prior to initial administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to initial administration.
5 Positive urine drug screening. 6 Those who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during hospitalization.
7 Regular drinkers within 6 months prior to screening, i.e., those who drank more than 14 units of alcohol per week, and/or those who could not stop drinking alcohol during their hospitalization, and/or test positive for breath alcohol.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Hongyun, Doctor | Contact | +8618611513192 | wanghy@pumch.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Science and Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| SYH2062-Matching placebo |
| Drug |
Normal saline matching volume of SYH2062 doses will be administered |
|
| Change from Baseline in in plasma renin activity |
| up to approximately 12 months |
| Change from Baseline in in angiotensin I | up to approximately 12 months |
| Change from Baseline in in angiotensin II | up to approximately 12 months |
| Change from Baseline in in plasma aldosterone | up to approximately 12 months |
| To characterize the Cmax of single dose of SYH2062 | Up to Day 3 |
| To characterize the AUC of single dose of SYH2062 | Up to Day 3 |
| Number of Participants With Anti- SYH2062 Antibodies | up to approximately 3 months |