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To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension

NCT07191899 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Suzhou Alphamab Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jiguang Wang, Doctor · Ruijin Hospital

  • Ningru Zhang, Doctor · The First Affiliated Hospital of Bengbu Medical University

  • Caie Wang, Doctor · The First Affiliated Hospital of Henan University of Science & Technology

  • Zhijuan Li, Doctor · The First Affiliated Hospital of Henan University of Science & Technology

  • Siyu Guan, Doctor · Xiang Yang Central Hospital

  • Lipeng Li, Doctor · Luoyang third people's Hospital

  • Jidong Zhang, Doctor · The Second Hospital of Hebei Medical University

  • ZhiJun Huang, Doctor · The Third Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191899 on ClinicalTrials.gov