Actively Recruiting
Study of the Safety, Tolerability, Pharmacokinetics and Food Effects of VV119 Capsules in Chinese Healthy Volunteers
Led by Vigonvita Life Sciences · Updated on 2025-06-11
82
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study
CONDITIONS
Official Title
Study of the Safety, Tolerability, Pharmacokinetics and Food Effects of VV119 Capsules in Chinese Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 45 years with body weight no less than 50.0 kg
- Female participants aged 18 to 60 years with body weight no less than 45.0 kg and BMI between 19.0 to 26.0 kg/m2
- Medically healthy with normal or clinically insignificant physical exam, vital sign, lab, and ECG results
- Male subjects willing to use effective contraception during the study and for 3 months after
- Females not of child-bearing potential
- Able to understand and follow study instructions and provide informed consent
You will not qualify if you...
- History or current diseases affecting major systems such as CNS, cardiovascular, respiratory, digestive, urinary, endocrine, blood, or eye diseases
- History of malignant tumors or other unsuitable diseases
- Mental disorders, brain dysfunction, suicide risk, or history of self-mutilation
- Surgical conditions affecting drug absorption or posing risk, including gastrointestinal surgery or urinary obstruction
- Known allergy to study drug or similar drugs
- Positive for hepatitis B surface antigen, syphilis antibody, hepatitis C antibody, or HIV antigen/antibody
- Recent surgery within 3 months, incomplete recovery, or planned surgery during trial
- Recent blood donation or loss exceeding specified amounts
- Use of prescription, OTC drugs, vitamins, or herbal products within 2 weeks before screening
- Use of drugs affecting CYP3A4, CYP3A5, CYP2D6 enzymes within 4 weeks before screening
- Participation in other clinical trials or use of trial drugs within 3 months
- Smoking more than 5 cigarettes per day or heavy caffeine intake, or unable to stop during study
- Alcohol abuse within 1 year or positive alcohol breath test
- Drug abuse history within 1 year or positive drug screen
- Family history of sudden cardiac death before age 40
- Abnormal vital signs or clinically significant ECG abnormalities
- Abnormal liver, kidney, or prolactin lab values
- Special dietary needs or dysphagia
- Refusal to avoid smoking, alcohol, caffeine, or strenuous exercise during trial
- Directly related to this clinical trial or deemed unsuitable by investigator for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100088
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
3
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