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

A Randomized, Double-blind, Placebo-Controlled, Single-Centre,Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: LV232; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201900
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Subjects will receive placebo orally for single dose.	Drug: Placebo; Placebo:1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg
Experimental: LV232; Subjects will receive LV232 orally for single dose.	Drug: LV232; Drug: LV232 1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events	7 days after treatment
Cmax	maximum observed plasma concentration	48 hours after administration
Tmax	time at which Cmax occurs	48 hours after administration
AUC0-t	area under the plasma concentration time curve from time zero to the last	48 hours after administration
AUC0-∞	area under the plasma concentration time curve from time zero to infinity	48 hours after administration
AUC0-24h	area under the plasma concentration time curve from time zero to 24 hours	48 hours after administration
t1/2	half life of elimination	48 hours after administration
CL/F	apparent clearance	48 hours after administration
Vd/F	apparent volume of distribution during the terminal phase	48 hours after administration
Ke	elimination rate constant	48 hours after administration
MRT	mean Resident Time	48 hours after administration
BP	Blood Plasma Ratio	48 hours after administration
BRPP	binding rate of plasma protein	48 hours after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
structural of metabolites	Structure of main metabolites of LV232 in plasma, feces and urine	From time zero up to 96 hours post-dose following oral administration
Ae	Cumulative excretion of LV232 and major metabolites in feces and urine	From time zero up to 96 hours post-dose following oral administration
Fe%	Percentage of LV232 and major metabolites in feces and urine	From time zero up to 96 hours post-dose following oral administration
CLr	renal clearance rate	From time zero up to 72 hours post-dose following oral administration
Genetic polymorphisms in drug metabolism	Influence of genetic polymorphisms in drug metabolism enzymes on pharmacokinetics and safety	Before administration

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: Chen Yu, Shanghai Xuhui Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): November 17, 2025
• Study Completion (Actual): November 17, 2025

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: September 30, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Phase I; Tolerability; Pharmacokinetic; dose-escalation; LV232
• Other Study ID Numbers: LV232-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No