HypertensionPhase 1NCT07254481
VB19055 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population
A Phase 1 study testing VB19055 in people with Hypertension, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- VB19055
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesChina
- Study dates
- 5 Oct 2025to Jul 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily participate in clinical trials, understand the nature of the study and any risks involved in participation, sign an informed consent form, and be willing to comply with the requirements specified in the protocol;
- Aged between 18 and 50 years (inclusive), healthy volunteers;
- Body mass index (BMI) between 18-26 kg/m² (inclusive), with minimum weight requirements of 50 kg (inclusive) for males and 45 kg (inclusive) for females;
- In generally good health, as determined by the investigator based on medical history, surgical history, complete physical examination, vital signs measurements, laboratory tests, 12-lead electrocardiogram (ECG), and chest X-ray results, with no evidence of clinical disease and confirmed to be healthy;
- For females of childbearing potential: Agree to use highly effective contraception (e.g., intrauterine device, hormonal contraceptives, or condoms) throughout the study and for 3 months after the last dose, with a negative serum pregnancy test at screening.
- For males: Agree to use effective contraception (specific methods detailed in Appendix 5) during the study and for 3 months after the last dose.
Who cannot join
- Known allergy to aldosterone synthase inhibitors or any components/excipients of the investigational drug;
- The clinically significant endocrine, metabolic, cardiovascular, respiratory, gastrointestinal, liver and kidney, nervous system (including the history of seizures) or any significant history of mental illness or mental disorder, or clinically significant diseases, conditions or other evidence, which the researcher believes will pose risks to the safety of the subjects or interfere with the development, conduct or completion of the study;
- Any known diseases or conditions that may interfere with drug absorption, distribution, metabolism or excretion (such as dysphagia or gastrointestinal diseases that affect drug absorption, or previous gastric surgery, vagotomy, enterotomy or any surgery that may interfere with gastrointestinal peristalsis, PH or absorption, etc.);
- Vaccination with active or attenuated vaccine within 4 weeks before screening or during the trial (except influenza vaccine);
- Drinking excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) per day, or drinking tea, coffee and/or caffeinated beverages within 48 hours before drug administration, or unable to stop drinking during the trial; Had a history of long-term consumption of a beverage or food rich in xanthine or grapefruit, or had taken any product rich in xanthine or grapefruit within 48 hours before administration；
- Smokers or those who used nicotine products excessively (≥5 cigarettes per day on average) in the 3 months before screening or who were unable to stop using any tobacco or nicotine-based products (snus, chewing tobacco, cigars, pipes, or nicotine-replacement products) during the trial；
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- Participants who had participated in a clinical trial of another drug and had taken any investigational drug within 3 months before the first dose；
- Use of corticosteroids within 3 months prior to the first dose；
- Within 3 months before the first dose of blood donation or blood loss≥400 ml, blood transfusion or use of blood products, or plans to test during or within 30 days after the last drug blood donors；
- Were heavy drinkers or regular drinkers in the 3 months before screening, which was defined as having consumed an average of 14 standard units of alcohol per week (one unit of alcohol =285mL of beer or 25mL of spirits or 125mL of wine), had a positive alcohol breath test at screening, or were unable to stop using any alcohol-containing product during the trial;
- Drug abuse screening is positive or in the past five years has a history of substance abuse or screening before 3 months used drugs；
- Blood pressure in the range of 90-140mmHg (systolic) or 50-90mmHg (diastolic) or pulse rate in the range of 50-100 beats/min during the screening period;Or postural hypotension (systolic blood pressure decreased ≥20mmHg or diastolic blood pressure decreased ≥ 10mmHg while standing)；
- During the screening period, any one of the infectious disease screening results of hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, HIV antibody and treponema pallidum antibody was positive；
- The presence of uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections, unless treated prior to study treatment and had returned to normal；
- Use of any medication (including prescription drugs, over-the-counter drugs, herbal medicines, functional vitamins, supplements, etc.) within 14 days before the first dose (or within 5 half-lives of the drug used, whichever is longer) that the investigator considers may affect the evaluation of the pharmacokinetic characteristics of the study drug or interfere with the study procedures or affect the safety assessment；
- Serum potassium level <3.5 mmol/L or ≥5.0 mmol/L at screening and admission；
- Subjects with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >1.5 times the upper limit of normal (ULN) at screening or admission；
- Abnormal renal function (estimated glomerular filtration rate < 90 mL/ minute /1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation, as described in Appendix 1: CKD-EPI equation)；
- Family history of long or short QT syndrome, history of syncope or torsdes pointes, heart failure, or clinically significant/symptomatic bradycardia, and risk factors including uncontrolled hypokalemia, hypocalcemia, or hypomagnesemia.For participants in the QT/QTc study, use of antiarrhythmic drugs, inotropic drugs, beta-blockers, calcium-channel blockers, quinolones, and other drugs with a risk of prolonging the QT/QTc interval or causing torsdes pointes within 4 weeks before the first dose (see Appendix 3 for details); And prolonged QTcF interval (> 450msec)；
- Clinically significant abnormal ECG findings at screening or admission as judged by the investigator; Strenuous physical training or excessive exercise (e.g., long-distance running, weight lifting, or any physical activity to which the participant is not accustomed) from 7 days before administration until the end of the study；
- The investigator judged that the subject had other conditions that were not suitable for participation in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou
Ying Wang, China 86+0571-56007501, nancywangying@163.com
- Not yet recruiting
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Jiguang Wang, China 86+13764189476, jiguangw@163.com
Jing Sun, China 86+13816899762, sunjingrjxh@163.com
About this study
Official title: A Phase 1, Randomized, Double-Blind Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Food Effects, and QT/QTc Interval Impact of VB19055 Tablets in Healthy Chinese Adult Subjects
The purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population.
Read the detailed description
This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects.
Part A is a single ascending dose study of VB19055 tablets in healthy Chinese adult participants. Part B is a randomized, single-dose, two-period, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of VB19055 tablets in healthy Chinese adult participants.Part C is a multiple ascending dose study of VB19055 tablets in healthy Chinese adult participants.
Part A will be conducted first, and Parts B and C will be initiated when appropriate based on the preliminary data obtained during the study.
- Conditions
- Hypertension
- Being tested
- VB19055, VB19055 placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB19055Drug
In this part, VB19055 tablets will be administered as a single or multiple oral dose.
VB19055 placeboDrug
In this part, VB19055 placebo tablets will be administered as a single or multiple oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses (SAD, Part A) | Experimental | In this part, 5 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 3:1 ratio to receive either VB19055 or placebo. Receives: Drug: VB19055; Drug: VB19055 placebo |
| Food Effect (FE, Part B) | Experimental | 14 participants and single dose food effect cohort. This part is open-label, two sequence, two-period, crossover design. Receives: Drug: VB19055 |
| Single Ascending Doses (MAD,Part C) | Experimental | In this part, 4 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in an 3:1ratio to receive either VB19055 or placebo. Receives: Drug: VB19055; Drug: VB19055 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
The rate of Adverse events occur during the whole study
Measured: Average half a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start5 Oct 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiguang Wang, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254481
- Sponsor's protocol ID
- VB19055-001
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Nov 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Food Effects, and QT/QTc Interval Impact of VB19055 Tablets in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT07254481
- Acronym / sponsor ID
- VB19055-001
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Nov 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 purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population.
Detailed description
This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects.
Part A is a single ascending dose study of VB19055 tablets in healthy Chinese adult participants. Part B is a randomized, single-dose, two-period, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of VB19055 tablets in healthy Chinese adult participants.Part C is a multiple ascending dose study of VB19055 tablets in healthy Chinese adult participants.
Part A will be conducted first, and Parts B and C will be initiated when appropriate based on the preliminary data obtained during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses (SAD, Part A) | Experimental | Drug: VB19055, Drug: VB19055 placeboIn this part, 5 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 3:1 ratio to receive either VB19055 or placebo. |
| Food Effect (FE, Part B) | Experimental | Drug: VB1905514 participants and single dose food effect cohort. This part is open-label, two sequence, two-period, crossover design. |
| Single Ascending Doses (MAD,Part C) | Experimental | Drug: VB19055, Drug: VB19055 placeboIn this part, 4 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in an 3:1ratio to receive either VB19055 or placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily participate in clinical trials, understand the nature of the study and any risks involved in participation, sign an informed consent form, and be willing to comply with the requirements specified in the protocol;
- Aged between 18 and 50 years (inclusive), healthy volunteers;
- Body mass index (BMI) between 18-26 kg/m² (inclusive), with minimum weight requirements of 50 kg (inclusive) for males and 45 kg (inclusive) for females;
- In generally good health, as determined by the investigator based on medical history, surgical history, complete physical examination, vital signs measurements, laboratory tests, 12-lead electrocardiogram (ECG), and chest X-ray results, with no evidence of clinical disease and confirmed to be healthy;
- For females of childbearing potential: Agree to use highly effective contraception (e.g., intrauterine device, hormonal contraceptives, or condoms) throughout the study and for 3 months after the last dose, with a negative serum pregnancy test at screening.
Key exclusion criteria (21 listed)
- Known allergy to aldosterone synthase inhibitors or any components/excipients of the investigational drug;
- The clinically significant endocrine, metabolic, cardiovascular, respiratory, gastrointestinal, liver and kidney, nervous system (including the history of seizures) or any significant history of mental illness or mental disorder, or clinically significant diseases, conditions or other evidence, which the researcher believes will pose risks to the safety of the subjects or interfere with the development, conduct or completion of the study;
- Any known diseases or conditions that may interfere with drug absorption, distribution, metabolism or excretion (such as dysphagia or gastrointestinal diseases that affect drug absorption, or previous gastric surgery, vagotomy, enterotomy or any surgery that may interfere with gastrointestinal peristalsis, PH or absorption, etc.);
- Vaccination with active or attenuated vaccine within 4 weeks before screening or during the trial (except influenza vaccine);
- Drinking excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) per day, or drinking tea, coffee and/or caffeinated beverages within 48 hours before drug administration, or unable to stop drinking during the trial; Had a history of long-term consumption of a beverage or food rich in xanthine or grapefruit, or had taken any product rich in xanthine or grapefruit within 48 hours before administration；
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 |
|---|---|---|
| VB19055In this part, VB19055 tablets will be administered as a single or multiple oral dose. | Drug | Food Effect (FE, Part B), Single Ascending Doses (MAD,Part C), Single Ascending Doses (SAD, Part A) |
| VB19055 placeboIn this part, VB19055 placebo tablets will be administered as a single or multiple oral dose. | Drug | Single Ascending Doses (MAD,Part C), Single Ascending Doses (SAD, Part A) |
Primary outcome
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
Time frame: Average half a month
The rate of Adverse events occur during the whole study
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 28 Nov 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 principal investigator
Ruijin Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VB19055 in people with Hypertension, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 2 sites 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 6 inclusion and 21 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 Jia Song (China 86+18503817651, songjia@vybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0 (time frame: Average half a month). 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 28 Nov 2025.