HypertensionPhase 1NCT07191899
To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension
A Phase 1 study testing KN060 and 0.9% Sodium Chloride Injection in people with Hypertension, run by Suzhou Alphamab Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- KN060 and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2025to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
- 12-lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;
- echocardiography revealed heart failure:LVEF< 50%; abnormal ventricular diastolic function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Jiguang Wang, Doctor, +86 13725517405, jiguangw@163.com
About this study
Official title: Randomized, Single-blind, Placebo-controlled Exploratory Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety, Tolerability of KN060 in Patients With Essential Hypertension
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:
Read more
- 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
- Being tested
- KN060, 0.9% Sodium Chloride Injection
- Keywords
- Essential hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN060Drug
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
0.9% Sodium Chloride InjectionDrug
0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.9% Sodium Chloride Injection | Placebo comparator | 0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks Receives: 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 Receives: Drug: KN060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Systolic Blood Pressure (SBP) Change From Baseline in 24hABPM Adding KN060 or Placebo for 12 Weeks
Measured: 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
Change from Baseline in Mean Diastolic Blood Pressure (DBP) at 24hABPM Proportion of patients with reductions from baseline in mean nighttime/daytime SBP by ABPM Proportion of patients achieving blood pressure targets by ABPM (24-hour mean blood pressure < 130/80 mmHg, daytime mean blood pressure < 135/85 mmHg, nighttime mean blood pressure < 120/70 mmHg) Change from Baseline in AOBP Mean Sitting SBP, DBP Proportion of patients achieving sitting blood pressure targets for AOBP (< 140/90 mmHg, < 130/80 mmHg) Incidence of adverse events (TEAEs), serious adverse events (SAEs) and drug-related adverse events (TRAEs) in each group during the trial (treatment period and follow-up period) Pharmacokinetics and pharmacodynamics of KN060 in patients with essential hypertension Immunogenicity of KN060 in Patients with Essential Hypertension
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start5 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Alphamab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiguang Wang, Doctor, Principal investigator, Ruijin HospitalNingru Zhang, Doctor, Principal investigator, The First Affiliated Hospital of Bengbu Medical UniversityCaie Wang, Doctor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyZhijuan Li, Doctor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologySiyu Guan, Doctor, Principal investigator, Xiang Yang Central HospitalLipeng Li, Doctor, Principal investigator, Luoyang third people's HospitalJidong Zhang, Doctor, Principal investigator, The Second Hospital of Hebei Medical UniversityZhiJun Huang, Doctor, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191899
- Sponsor's protocol ID
- KN060-D-102
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind, Placebo-controlled Exploratory Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety, Tolerability of KN060 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT07191899
- Acronym / sponsor ID
- KN060-D-102
- Conditions
- Hypertension
- Keywords
- Essential hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suzhou Alphamab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9% Sodium Chloride Injection | Placebo comparator | Drug: 0.9% Sodium Chloride Injection0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks |
| KN060 | Experimental | Drug: KN060The 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KN060The 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 |
| 0.9% Sodium Chloride Injection0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks | Drug | 0.9% Sodium Chloride Injection |
Primary outcome
Mean Systolic Blood Pressure (SBP) Change From Baseline in 24hABPM Adding KN060 or Placebo for 12 Weeks
Time frame: KN060 or placebo for 12 weeks
1 secondary outcome
Proportion of subjects achieving target blood pressure control, incidence of adverse events, pharmacokinetic, pharmacodynamic and immunogenicity characteristics of KN060 in patients with essential hypertension
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiguang Wang, Doctor principal investigator
Ruijin Hospital
Ningru Zhang, Doctor principal investigator
The First Affiliated Hospital of Bengbu Medical University
Caie Wang, Doctor principal investigator
The First Affiliated Hospital of Henan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KN060 and 0.9% Sodium Chloride Injection in people with Hypertension, run by Suzhou Alphamab Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanrong Dong, Master (+86 18914005458, yanrongdong@alphamab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Systolic Blood Pressure (SBP) Change From Baseline in 24hABPM Adding KN060 or Placebo for 12 Weeks (time frame: KN060 or placebo for 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.