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: * To verify the efficacy of KN060 in patients with essential hypertension * Safety of KN060 in Subjects Treated for Essential Hypertension Researchers will compare KN060 to placebo (0.9% sodium chloride 100ml) to assess the antihypertensive effect of KN060. Subjects will : * Receive KN060 or placebo by intravenous drip every two weeks for 6 doses. * AOBP, 24hABPM, HBPM,and safety were monitored and recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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
0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGMean Systolic Blood Pressure (SBP) Change From Baseline in 24hABPM Adding KN060 or Placebo for 12 Weeks
Time frame: KN060 or placebo for 12 weeks
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
Time frame: 12 weeks
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