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CompletedNCT06070857Updated Dec 16, 2025

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

A Phase 1 interventional study of LV232 and Placebo in Healthy Subjects, sponsored by Vigonvita Life Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Vigonvita Life Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • LV232
  • Phase I
  • dose-escalation
  • Tolerability
  • Pharmacokinetic
03

In context

Lead sponsor

Vigonvita Life Sciences is the lead sponsor of 35 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    LV232

    Subjects will receive LV232 orally for single dose.

    Drug: LV232

  • Experimental
    Placebo

    Subjects will receive placebo orally for single dose.

    Drug: Placebo

Interventions

  • DrugLV232

    Drug: LV232 1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg

  • DrugPlacebo

    Placebo:1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Incidence of Treatment-Emergent Adverse Events

    Time frame: 7 days after treatment

  2. Cmax

    maximum observed plasma concentration

    Time frame: 48 hours after administration

  3. AUC0-t

    area under the plasma concentration time curve from time zero to the last

    Time frame: 48 hours after administration

  4. AUC0-∞

    area under the plasma concentration time curve from time zero to infinity

    Time frame: 48 hours after administration

  5. AUC0-24h

    area under the plasma concentration time curve from time zero to 24 hours

    Time frame: 48 hours after administration

  6. Tmax

    time at which Cmax occurs

    Time frame: 48 hours after administration

  7. t1/2

    half life of elimination

    Time frame: 48 hours after administration

  8. CL/F

    apparent clearance

    Time frame: 48 hours after administration

  9. Vd/F

    apparent volume of distribution during the terminal phase

    Time frame: 48 hours after administration

  10. Ke

    elimination rate constant

    Time frame: 48 hours after administration

  11. MRT

    mean Resident Time

    Time frame: 48 hours after administration

  12. BP

    Blood Plasma Ratio

    Time frame: 48 hours after administration

  13. BRPP

    binding rate of plasma protein

    Time frame: 48 hours after administration

Secondary outcomes

  1. structural of metabolites

    Structure of main metabolites of LV232 in plasma, feces and urine

    Time frame: From time zero up to 96 hours post-dose following oral administration

  2. Ae

    Cumulative excretion of LV232 and major metabolites in feces and urine

    Time frame: From time zero up to 96 hours post-dose following oral administration

  3. Fe%

    Percentage of LV232 and major metabolites in feces and urine

    Time frame: From time zero up to 96 hours post-dose following oral administration

  4. CLr

    renal clearance rate

    Time frame: From time zero up to 72 hours post-dose following oral administration

  5. Genetic polymorphisms in drug metabolism

    Influence of genetic polymorphisms in drug metabolism enzymes on pharmacokinetics and safety

    Time frame: Before administration

07

Study locations

1 site
  • Shanghai Xuhui Central Hospital
    Shanghai, Shanghai Municipality 201900, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06070857
Lead sponsor
Vigonvita Life Sciences
Responsible party
Sponsor
First posted
Oct 6, 2023
Start date
Oct 5, 2023
Primary completion
Nov 17, 2025
Completion
Nov 17, 2025
Last update
Dec 16, 2025

Study contacts

Chen Yu
principal investigator · Shanghai Xuhui Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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