Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules

Launched by VIGONVITA LIFE SCIENCES · Feb 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LV232, which comes in capsule form. The main goal is to understand how safe it is and how the body processes it when taken in different amounts, as well as how food affects its absorption. The trial will involve 48 healthy adults aged between 18 and 45 years. Participants will be monitored closely to ensure their safety and comfort throughout the study.

To be eligible for this trial, participants should be healthy individuals within the specified age range, have a certain body weight and height, and must not have any serious medical conditions or allergies. They also need to be willing to follow instructions, including using effective birth control during the study. Those who join can expect regular check-ups, tests, and to take the capsules as directed. It’s important to know that individuals with certain health issues, recent drug use, or who smoke or drink heavily may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 to 45 years old, males or females;
• • 2. Body weight no less than 50.0 kg for male, no less than 45.0 kg for female,Body Mass Index of 19.0 to 26.0kg/m2;
• • 3. Physical examination, vital signs examination, laboratory examination, electrocardiogram examination and B-ultrasound examination results were normal or abnormal without clinical significant;
• • 4. Subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed;
• • 5. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.
• Exclusion Criteria:
• • 1. Subjects with hypersensitivity to LV232 or any of the excipients;
• • 2. Subjects with allergic diseases or allergic constitution;
• • 3. Subjects with skin diseases or a history of skin allergies;
• • 4. Subjects with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, Hematologic System, metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
• • 5. Blood donation or blood loss ≥ 400 mL within 3 months , or have a history of blood product use history
• • 6. Subjects who have participated in clinical trials of other drugs within 3 months before screening;
• • 7. Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products orally within 2 weeks before screening;
• • 8. Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content);
• • 9. Subjects who smoked more than 10 cigarettes or equivalent amounts of tobacco a day within one year before screening;
• • 10. Subjects who can't quit smoking and drinking during the experiment;
• • 11. Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);
• • 12. Abnormal and clinically significant chest radiographs (anteroposterior);
• • 13. B ultrasound examination showed moderate to severe fatty liver;
• • 14. Pregnant or lactating woman or male subjects whose spouse has a child care plan within 3 months;
• • 15. The investigator believes that there are other factors that are not suitable for participating in this trial.