NCT07191899

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Suzhou Alphamab Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	KN060	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
DRUG	0.9% Sodium Chloride Injection	0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2025-09-25
• Last updated: 2025-09-25

Locations

1 site across 1 country: China