NCT07191899RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Jun 2025
- Start date
- 5 Aug 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Suzhou Alphamab Co., Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT07191899
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 5 Aug 2025 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- any cardiovascular event within 6 months prior to screening
Other illness
- 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;
- 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;
- 12-lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;
Lab values
- 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%;
- echocardiography revealed heart failure:LVEF\< 50%; abnormal ventricular diastolic function
Who the study is looking for
- 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;
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.