Status:
RECRUITING
To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension
Lead Sponsor:
Suzhou Alphamab Co., Ltd.
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 obj...
Eligibility Criteria
Inclusion
- men or women ≥ 18 years of age and ≤ 65 years of age;
- patients with essential hypertension who are not receiving drug therapy or are receiving stable monotherapy (stable therapy: no change in antihypertensive drugs and doses within 30 days before screening);
- AOBP mean sitting SBP ≥ 140 and \< 180 mmHg (at least 5 minutes rest before measurement, 3 measurements averaged over at least 1 minute apart) and mean SBP ≥ 130 and ≤ 160 mmHg at 24 hours ABPM;
Exclusion
- secondary hypertension: kidney disease, endocrine disease, cardiovascular disease and moderate to severe obstructive sleep apnea without CPAP treatment;
- Grade 3 hypertension (severe): mean AOBP sitting SBP ≥ 180 mmHg, and/or DBP ≥ 110 mmHg; mean ABPM SBP \> 160 mmHg, and/or mean DBP ≥ 100 mmHg;
- Patients with a history of hypertensive emergencies, or hypertensive sub-emergencies who have severe hypertension with headache, chest tightness, irritability, and epistaxis;
- high risk of bleeding or abnormal relevant indicators;
- long-term use of anticoagulants or antiplatelet drugs, including aspirin at any dose, due to treatment;
- currently using, or within 30 days before dosing or expected to use any drug or other component known to affect blood pressure during the study;
- Type 2 diabetes with substandard blood glucose control: fasting blood glucose \> 7.8 mmol/L, or 2-hour postprandial blood glucose/random blood glucose \> 10.0 mmol/L, or HbA1c \> 7%;
- any cardiovascular event within 6 months prior to screening
- unstable heart disease, such as uncontrolled symptomatic arrhythmia, atrial fibrillation, heart failure NYHA ≥ III, severe left ventricular hypertrophy, or a history of valvular heart disease;
- 12-lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;
- echocardiography revealed heart failure:LVEF\< 50%; abnormal ventricular diastolic function
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07191899
Start Date
August 5 2025
End Date
December 30 2027
Last Update
September 25 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China