Actively Recruiting
VB19055 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population
Led by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. · Updated on 2025-11-28
86
Participants Needed
2
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population.
CONDITIONS
Official Title
VB19055 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers aged 18 to 50 years who are healthy
- Body mass index between 18 and 26 kg/m8, with minimum weight of 50 kg for males and 45 kg for females
- Willingness to participate, understand study risks, and sign informed consent
- Good health confirmed by medical history, physical exam, vital signs, lab tests, ECG, and chest X-ray
- For women of childbearing potential, agreement to use highly effective contraception during and for 3 months after the study with a negative pregnancy test
- For men, agreement to use effective contraception during and for 3 months after the study
You will not qualify if you...
- Allergy to aldosterone synthase inhibitors or any ingredients of the study drug
- Significant endocrine, metabolic, cardiovascular, respiratory, gastrointestinal, liver, kidney, nervous system, or mental health conditions
- Conditions affecting drug absorption or metabolism, including certain surgeries
- Vaccination with active or attenuated vaccines within 4 weeks before or during the study (except influenza vaccine)
- Excessive consumption of tea, coffee, caffeine, xanthine, or grapefruit products
- Smoking more than 5 cigarettes per day in the past 3 months or inability to stop during the study
- Participation in other clinical trials or investigational drug use within 3 months
- Use of corticosteroids within 3 months
- Recent blood donation or transfusion within specified timeframes
- Heavy or regular alcohol use exceeding 14 units per week or positive alcohol breath test
- Positive drug abuse screening or history of substance abuse
- Blood pressure or pulse outside specified healthy ranges or postural hypotension
- Positive infectious disease tests for hepatitis B, hepatitis C, HIV, or syphilis
- Active uncontrolled infections
- Use of medications affecting pharmacokinetics or safety within 14 days before dosing
- Abnormal potassium levels or liver function tests
- Impaired kidney function
- Family or personal history of heart rhythm disorders or abnormal ECG findings
- Strenuous physical training or excessive exercise before and during the study
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hangzhou First People's Hospital
Hangzhou, China
Actively Recruiting
2
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Not Yet Recruiting
Research Team
J
Jia Song
CONTACT
X
Xiaoqi Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here