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Healthy SubjectsPhase 1NCT06279533

Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules

A Phase 1 study testing LV232 in people with Healthy Subjects, run by Vigonvita Life Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
LV232
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
1 siteChina
Study dates
27 Feb 2024to 17 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Xuhui Central Hospital

    Shanghai

Other trials in China

About this study

Official title: Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules in Chinese Healthy Volunteers

This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement.

Read the detailed description

PK characteristics of multiple ascending doses study is used randomized, double-blinded, placebo-controlled, single-center design. LV232/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose groups (15mg, 40mg and 60mg), 8 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1. Investigational product is orally administrated QD for day1, day3~day9. When 7th day visit after last dose (D15) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started or adjusted.

FE study is a single-center, randomized, open-label, three-period crossover design. 24 healthy subjects divided into 2 groups (20mg、60mg) will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started.Investigational product administration plan given below: 12 healthy subjects in each group will be randomized to 3 sub-groups, i.e., Group A, Group B, Group C, with 4 subjects in each sub-group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. The wash-out period is 5 days.

Being tested
LV232/Placebo, LV232
Keywords
LV232, Phase I, dose-escalation, Tolerability, Pharmacokinetic, food effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LV232/PlaceboDrug

    Also called LV232 15mg, LV232 40mg, LV232 60mg

    Drug: LV232 15mg Group:

    6 subjects will receive LV232 15mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.

    Drug: LV232 40mg Group:

    6 subjects will receive LV232 40mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.

    Drug: LV232 60mg Group:

    6 subjects will receive LV232 60mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.

  • LV232Drug

    Also called LV232 20mg, LV232 60mg

    Drug: LV232 20mg Group:

    12 subjects will receive LV232 20mg, orally

    Drug: LV232 60mg Group:

    12 subjects will receive LV232 60mg, orally

Study groups in NCT06279533
Study groupRoleWhat they receive
PK characteristics of multiple ascending doses studyExperimentalThere are 24 subjects devided into 3 dose groups (15mg, 40mg and 60mg).8 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1. LV232/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. Investigational product is orally administrated QD for day1, day3~day9. When 7th day visit after last dose (D15) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started or adjusted.
Receives: Drug: LV232/Placebo
FE studyExperimental24 healthy subjects divided into 2 group (20mg and 60mg) will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started.Investigational product administration plan given below: 12 healthy subjects in each group will be randomized to 3 sub-groups, i.e., Group A, Group B, Group C, with 4 subjects in each sub-group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. Wash-out period is 5 days.
Receives: Drug: LV232

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tmax

    Maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 72 hours postdose

  2. Cmax

    Maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 72 hours postdose

  3. T1/2

    Terminal half life

    Measured: Calculated using concentration data collected from predose to 72 hours postdose

  4. AUC0-t

    Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration

    Measured: Calculated using concentration data collected from predose to 72 hours postdose

  5. AUC0-24h

    Area under the serum concentration time profile from time zero to the time of 24h

    Measured: Calculated using concentration data collected from predose to 24 hours postdose

  6. AUC0-∞

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity

    Measured: Calculated using concentration data collected from predose to 72 hours postdose

Secondary outcomes (4)

  1. Number of participants with treatment emergent treatment-related adverse event(s)

    Frequency, severity and causal relationship of treatment emergent adverse events

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

  2. Laboratory test

    Number of participants with laboratory test findings of potential clinical importance

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

  3. Vital signs

    Number of participants with vital signs findings of potential clinical importance

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

  4. Number of participants with ECG findings of potential clinical importance

    Number of subjects with change from baseline in electrocardiogram (ECG) parameters

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start27 Feb 2024
  3. Primary completion17 Dec 2024
  4. Study completion17 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
PK characteristics of multiple ascending doses study is parallel design, and FE study is crossover design
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279533
Sponsor's protocol ID
LV232-02
Status last verified
Feb 2025
First submitted
31 Jan 2024
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LV232 in people with Healthy Subjects, run by Vigonvita Life Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tmax (time frame: Calculated using concentration data collected from predose to 72 hours postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06279533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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