KN060 for adults with 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

This trial will try an intravenous medicine called KN060 to see if it lowers blood pressure in adults with essential hypertension over 12 weeks.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Suzhou Alphamab Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07191899 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, placebo-controlled study gives participants KN060 or saline by intravenous drip every two weeks for six doses and compares change in systolic blood pressure to placebo over 12 weeks. Blood pressure is measured by automated office BP (AOBP), 24-hour ambulatory BP monitoring (ABPM), and home BP monitoring (HBPM), while safety, pharmacokinetics/pharmacodynamics, and immunogenicity are also tracked. The primary endpoint is change from baseline in systolic blood pressure; secondary endpoints include safety and tolerability and PK/PD measures. The trial enrolls adults with essential hypertension who are untreated or on stable single-agent therapy.

Who should consider this trial

Good fit: Adults 18–65 with essential hypertension who are untreated or on stable monotherapy and who meet the study BP ranges (AOBP mean sitting SBP ≥140 and <180 mmHg and 24‑hour ABPM mean SBP ≥130 and ≤160 mmHg) are ideal candidates.

Not a fit: Patients with secondary hypertension, severe (grade 3) hypertension, recent hypertensive emergencies, or uncontrolled comorbid conditions are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, KN060 could become a new option to lower systolic blood pressure in adults with essential hypertension.

How similar studies have performed: Clinical experience with similar IV or biologic antihypertensive agents is limited, so this approach is relatively novel and early in clinical testing.

Eligibility criteria

Inclusion Criteria:

1. men or women ≥ 18 years of age and ≤ 65 years of age;
2. 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);
3. 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;

Exclusion Criteria:

1. secondary hypertension: kidney disease, endocrine disease, cardiovascular disease and moderate to severe obstructive sleep apnea without CPAP treatment;
2. 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;
3. Patients with a history of hypertensive emergencies, or hypertensive sub-emergencies who have severe hypertension with headache, chest tightness, irritability, and epistaxis;
4. high risk of bleeding or abnormal relevant indicators;
5. long-term use of anticoagulants or antiplatelet drugs, including aspirin at any dose, due to treatment;
6. 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;
7. 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%;
8. any cardiovascular event within 6 months prior to screening
9. 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;
10. 12-lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;
11. echocardiography revealed heart failure:LVEF\< 50%; abnormal ventricular diastolic function

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jiguang Wang, Doctor — Ruijin Hospital
• Study coordinator: Yanrong Dong, Master

Conditions Hypertension; Essential hypertension