Actively Recruiting
Study of the Safety, Tolerability, Pharmacokinetics of VV261 Tablets in Chinese Healthy Volunteers
Led by Vigonvita Life Sciences · Updated on 2026-03-03
58
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults.
CONDITIONS
Official Title
Study of the Safety, Tolerability, Pharmacokinetics of VV261 Tablets in Chinese Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 45 years old, males or females
- Males must weigh at least 50 kg; females must weigh at least 45 kg
- Body mass index between 19 and 26 kg/m2
- Normal or clinically insignificant abnormal results in vital signs, physical exam, lab tests, ECG, chest CT, and abdominal ultrasound
- Willing to use proper contraception during the study and for 3 months after last dose
- Able to understand and follow study instructions and sign informed consent
You will not qualify if you...
- Allergy to VV261 or its ingredients
- History of allergic diseases such as asthma, urticaria, or eczema
- Any central nervous, cardiovascular, gastrointestinal, respiratory, urinary, hematologic, metabolic, or psychiatric disorders requiring medical treatment
- History of gastrointestinal diseases affecting drug absorption
- History of bone marrow or immune system diseases or treatments like chemotherapy
- History of spleen disease
- Abnormal blood cell counts or liver function tests with clinical significance
- Blood transfusions or heavy blood loss (>400 mL) within 3 months prior to screening
- Participation in clinical trials or use of drugs within 3 months prior to screening
- Use of any medications or health products within 2 weeks prior to screening
- Vaccination within 2 weeks before screening or planned vaccination during study or within 1 week after
- History of drug abuse or positive drug screening within 1 year
- Excessive alcohol consumption or smoking within 1 year prior to screening
- Unable or unwilling to stop smoking or drinking during the study
- Positive for hepatitis B, hepatitis C, syphilis, or HIV
- Unable to tolerate blood collection or prone to fainting
- Lactose intolerance or inability to follow a standard diet
- Difficulty swallowing tablets
- Pregnant or breastfeeding women or males with partners planning pregnancy within 3 months
- Any other factors the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230031
Actively Recruiting
Research Team
H
Huaqing Duan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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