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The primary objective of this study is to compare the change from baseline in systolic blood pressure between KN060 and placebo in patients with essential hypertension over 12 weeks; the secondary objectives are to assess the safety and tolerability of KN060 and to assess the pharmacokinetic and pharmacodynamic properties and immunogenicity of KN060 in patients with essential hypertension.
The main questions it aims to answer are:
Subjects will :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.9% Sodium Chloride Injection | Placebo Comparator | 0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks |
|
| KN060 | Experimental | The dose was calculated based on the fasting body weight of the subject D1, and the corresponding volume of KN060 was drawn and added to 0.9% sodium chloride injection to prepare a 100 ml solution by intravenous drip every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN060 | Drug | The dose was calculated based on the fasting body weight of the subject D1, and the corresponding volume of KN060 was drawn and added to 0.9% sodium chloride injection to prepare a 100 ml solution by intravenous drip every two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Systolic Blood Pressure (SBP) Change From Baseline in 24hABPM Adding KN060 or Placebo for 12 Weeks | KN060 or placebo for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving target blood pressure control, incidence of adverse events, pharmacokinetic, pharmacodynamic and immunogenicity characteristics of KN060 in patients with essential hypertension | Change from Baseline in Mean Diastolic Blood Pressure (DBP) at 24hABPM Proportion of patients with reductions from baseline in mean nighttime/daytime SBP by ABPM Proportion of patients achieving blood pressure targets by ABPM (24-hour mean blood pressure < 130/80 mmHg, daytime mean blood pressure < 135/85 mmHg, nighttime mean blood pressure < 120/70 mmHg) Change from Baseline in AOBP Mean Sitting SBP, DBP Proportion of patients achieving sitting blood pressure targets for AOBP (< 140/90 mmHg, < 130/80 mmHg) Incidence of adverse events (TEAEs), serious adverse events (SAEs) and drug-related adverse events (TRAEs) in each group during the trial (treatment period and follow-up period) Pharmacokinetics and pharmacodynamics of KN060 in patients with essential hypertension Immunogenicity of KN060 in Patients with Essential Hypertension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanrong Dong, Master | Contact | +86 18914005458 | yanrongdong@alphamab.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiguang Wang, Doctor | Ruijin Hospital | Principal Investigator |
| Ningru Zhang, Doctor | The First Affiliated Hospital of Bengbu Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.9% Sodium Chloride Injection | Drug | 0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks |
|
| 12 weeks |
| Caie Wang, Doctor |
| The First Affiliated Hospital of Henan University of Science and Technology |
| Principal Investigator |
| Zhijuan Li, Doctor | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Siyu Guan, Doctor | Xiang Yang Central Hospital | Principal Investigator |
| Lipeng Li, Doctor | Luoyang third people's Hospital | Principal Investigator |
| Jidong Zhang, Doctor | The Second Hospital of Hebei Medical University | Principal Investigator |
| ZhiJun Huang, Doctor | The Third Xiangya Hospital of Central South University | Principal Investigator |
| D017670 |
| Sodium Compounds |