RecruitingPhase 1NCT07191899

To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension

Randomized, Single-blind, Placebo-controlled Exploratory Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety, Tolerability of KN060 in Patients With Essential Hypertension

Sponsor

Suzhou Alphamab Co., Ltd.

Enrollment

60 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Hypertension

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 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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called KN060 for adults with essential hypertension (high blood pressure with no identifiable cause) whose blood pressure is not fully controlled on no medication or one blood pressure medication. **You may be eligible if...** - You are between 18 and 65 years old - You have essential hypertension (high blood pressure) either untreated or on one stable medication - Your blood pressure readings are in the study's target range (systolic 140–179 mmHg at the clinic) **You may NOT be eligible if...** - Your high blood pressure is caused by another condition (kidney disease, hormonal disorder, or sleep apnea without CPAP) - Your blood pressure is severely high (above 180/110 mmHg) - You have had a hypertensive emergency or heart attack/stroke in the past 6 months - You have uncontrolled diabetes - You are on blood thinners or aspirin regularly for another condition - You have serious heart rhythm problems or heart failure - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKN060

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

DRUG0.9% Sodium Chloride Injection

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