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

Vigonvita Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: LV232

Study type: Interventional

Funder types: Industry

Identifiers

NCT06070857

LV232-01

Details and patient eligibility

About

The study consists of 10 dose groups, 8 subjects in each group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and pharmacokinetics characteristics.

Full description

The dose levels are planned at 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg,40 mg, 60 mg ,90 mg and 120mg. 6 subjects in each group will receive LV232 tablets and 2 subjects will receive placebo. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained.1 mg dose group will be given by sentinel administration (i.e. 1 study drug, 1 placebo). Subjects who receive sentinel administration will be observed for 48 hours and investigator will evaluate the safety parameters (including symptoms, vital signs, physical examination, etc.).Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.

Enrollment: 81 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups

LV232

Experimental group

Description:

Subjects will receive LV232 orally for single dose.

Treatment:

Drug: LV232

Placebo

Experimental group

Description:

Subjects will receive placebo orally for single dose.

Treatment:

Drug: Placebo