Lung fibrosis
Conditions
Interventions
SAD:VS-2218 ASD Tablet/Placebo
Food Effect:VS-2218 ASD Tablet
MAD:VS-2218 ASD Tablet/Placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily signed an Informed Consent Form (ICF) prior to any study related procedures, and were capable of complying with study procedures. 2. Were between the ages of 18.0 and 45.0 years, inclusive. 3. Body mass index (BMI) of 19.0 to 26.0 kg/m2, inclusive, and body weight not less than 50.0 kg. 4. Considered healthy by the Investigator, based on subject’s reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs. 5. Female subjects or male subjects with female partners of child bearing potential were required to agree to use at least one acceptable forms of birth control for the duration of the study and for 3 months following the last administration of the drug and refrain from donating sperm or ova for this same period.
Exclusion criteria
Exclusion criteria: 1. Subjects who were hypersensitive to VS-2218 or any components of its formulations, or those with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those were allergic to two or more drugs or foods); 2. Clinically significant history of cardiovascular, metabolic, endocrine, renal, hepatic, digestive (such as gastrointestinal, pancreatic, cholecystic), hematologic, respiratory, dermatologic, neurologic, immunologic, gynecological, psychiatric disorders or other diseases as determined by the Investigator. 3. Known or suspected malignancy. 4. History of unexplained syncope, symptomatic hypotension or hypoglycemia. 5. Family history of long QTc syndrome. 6. Donated or lost >= 400ml of blood in the previous 3 months prior to screening. 7. Taken an investigational drug or participated in a clinical trial within 3 months or 5 half-lives (whichever is longer) prior to screening. 8. Subjects who had used prescription or traditional Chinese medicine within 2 weeks or 5 half-lives (whichever is longer) prior to randomization. 9. Subjects who had used over-the-counter (OTC) medication (other than occasionally or = 5 cigarettes per day within 3 months prior to screening or subjects are unwilling/unable to stop tobacco or nicotine intake from the time of screening until the end of the study. 14. Positive blood screen for human immunodeficiency virus (HIV), treponema pallidum antibody (TP), hepatitis B surface antigen (HBsAg) or hepatitis C antibody. 15. A history of prescription drug abuse or a positive screen for drugs of abuse at screening. 16. Female subjects who were pregnant, breastfeeding or intended to become pregnant, or a positive pregnancy test result at screening. 17. Poor venous access or difficult to swallow tablets. 18. Any condition or finding that in the investigators opinion would affect the evaluation of relevant indicators in this study Subject is unable to complete this study and are not suitable for participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Sign;Physical Examination;ECGs;Clinical laboratory test;AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Countries
China
Contacts
Public ContactZhu Luo
West China Hospital of Sichuan University
Outcome results
None listed