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

NCT06070857 | Completed Phase 1

• 1 other identifier: LV232-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

LV232; Phase I; dose-escalation; Tolerability; Pharmacokinetic

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• Tmax

  time at which Cmax occurs

  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 Outcomes (5)

• structural of metabolites

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

• Ae

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

• Fe%

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

• CLr

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

• Genetic polymorphisms in drug metabolism

  Before administration

Study Arms (2)

LV232

EXPERIMENTAL

Subjects will receive LV232 orally for single dose.

Drug: LV232

Placebo

EXPERIMENTAL

Subjects will receive placebo orally for single dose.

Drug: Placebo

Interventions

LV232 DRUG

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

LV232

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 45 years old, males or females;
• 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;
• Physical examination, vital signs examination, laboratory examination, electrocardiogram examination and B-ultrasound examination results were normal or abnormal without clinical significant;
• Subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed;
• 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.

You may not qualify if:

• Subjects with hypersensitivity to LV232 or any of the excipients;
• Subjects with allergic diseases or allergic constitution;
• Subjects with skin diseases or a history of skin allergies;
• 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;
• Blood donation or blood loss ≥ 400 mL within 3 months , or have a history of blood product use history
• Subjects who have participated in clinical trials of other drugs within 3 months before screening;
• Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products orally within 2 weeks before screening;
• 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);
• Subjects who smoked more than 10 cigarettes or equivalent amounts of tobacco a day within one year before screening;
• Subjects who can't quit smoking and drinking during the experiment;
• 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);
• Abnormal and clinically significant chest radiographs (anteroposterior);
• B ultrasound examination showed moderate to severe fatty liver;
• Pregnant or lactating woman or male subjects whose spouse has a child care plan within 3 months;
• The investigator believes that there are other factors that are not suitable for participating in this trial.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 201900, China

Location

Study Officials

• Chen Yu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 6, 2023
• Study Start: October 5, 2023
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)