RecruitingPhase 1

VB19055 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

China86 participantsStarted 2025-10-05

Plain-language summary

The purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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；
✕. 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；

What they're measuring

Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0

Timeframe: Average half a month

Trial details

NCT IDNCT07254481

SponsorZhejiang Yangli Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Jia Song

China 86+18503817651 songjia@vybio.com

View on ClinicalTrials.gov More Hypertension trials