To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension

ConditionHypertension

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorSuzhou Alphamab Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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
0.9% Sodium Chloride Injection
Drug
0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: 0.9% Sodium Chloride InjectionPlacebo comparator 1 intervention

Group B: KN060Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mean Systolic Blood Pressure (SBP) Change From Baseline in 24hABPM Adding KN060 or Placebo for 12 Weeks

Time frame

KN060 or placebo for 12 weeks

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Alphamab Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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