To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension

NCT07191899 | Recruiting Phase 1

• 1 other identifier: KN060-D-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Essential hypertension

Outcome Measures

Primary Outcomes (1)

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

  KN060 or placebo for 12 weeks

Secondary Outcomes (1)

• Proportion of subjects achieving target blood pressure control, incidence of adverse events, pharmacokinetic, pharmacodynamic and immunogenicity characteristics of KN060 in patients with essential hypertension

  12 weeks

Study Arms (2)

0.9% Sodium Chloride Injection

PLACEBO COMPARATOR

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

Drug: 0.9% Sodium Chloride Injection

KN060

EXPERIMENTAL

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: KN060

Interventions

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

KN060

0.9% Sodium Chloride Injection DRUG

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

0.9% Sodium Chloride Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• long-term use of anticoagulants or antiplatelet drugs, including aspirin at any dose, due to treatment;
• currently using, or within 30 days before dosing or expected to use any drug or other component known to affect blood pressure during the study;
• Type 2 diabetes with substandard blood glucose control: fasting blood glucose \> 7.8 mmol/L, or 2-hour postprandial blood glucose/random blood glucose \> 10.0 mmol/L, or HbA1c \> 7%;
• any cardiovascular event within 6 months prior to screening
• unstable heart disease, such as uncontrolled symptomatic arrhythmia, atrial fibrillation, heart failure NYHA ≥ III, severe left ventricular hypertrophy, or a history of valvular heart disease;
• lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;
• echocardiography revealed heart failure:LVEF\< 50%; abnormal ventricular diastolic function

Sponsors & Collaborators

• Suzhou Alphamab Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jiguang Wang, Doctor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Ningru Zhang, Doctor

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• Caie Wang, Doctor

  The First Affiliated Hospital of Henan University of Science & Technology

  PRINCIPAL INVESTIGATOR

• Zhijuan Li, Doctor

  The First Affiliated Hospital of Henan University of Science & Technology

  PRINCIPAL INVESTIGATOR

• Siyu Guan, Doctor

  Xiang Yang Central Hospital

  PRINCIPAL INVESTIGATOR

• Lipeng Li, Doctor

  Luoyang third people's Hospital

  PRINCIPAL INVESTIGATOR

• Jidong Zhang, Doctor

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• ZhiJun Huang, Doctor

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanrong Dong, Master

CONTACT

+86 18914005458; yanrongdong@alphamab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: September 25, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)