About this trial
The purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- VB19055
- VB19055 placebo