Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers

Launched by VIGONVITA LIFE SCIENCES · Sep 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LV232 to see how safe it is, how well it is tolerated, and how the body processes it. The trial is currently looking for healthy volunteers aged 18 to 45, both men and women, who meet certain health criteria. To be eligible, participants must weigh at least 50 kg for men and 45 kg for women, and have a normal health check-up, including vital signs and lab tests. It's important that participants are willing to use effective birth control during the study and for three months afterward.

If you join this trial, you will be placed in one of ten groups, with some receiving the LV232 capsules and others receiving a placebo (a pill with no active medication). Each group has eight participants, and the study will monitor how you feel and any side effects you may experience. Before participating, you must agree to the study's guidelines and sign a consent form. Overall, this trial aims to help researchers learn more about LV232 and its effects on the body, which could lead to important advancements in medication development.

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.