Healthy SubjectsPhase 1NCT06070857
Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers
A Phase 1 study testing LV232 in people with Healthy Subjects, run by Vigonvita Life Sciences at 1 site in China.
Trial 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 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
- 81 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2023to 17 Nov 2025
- 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;
Show all 15Show fewer
- 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, Shanghai Municipality, 201900
About this study
Official title: 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.
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.
- Conditions
- Healthy Subjects
- Being tested
- LV232, Placebo
- Keywords
- LV232, Phase I, dose-escalation, Tolerability, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV232Drug
Drug: LV232 1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg
PlaceboDrug
Placebo:1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg
| Study group | Role | What they receive |
|---|---|---|
| LV232 | Experimental | Subjects will receive LV232 orally for single dose. Receives: Drug: LV232 |
| Placebo | Experimental | Subjects will receive placebo orally for single dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: 7 days after treatment
Cmax
maximum observed plasma concentration
Measured: 48 hours after administration
AUC0-t
area under the plasma concentration time curve from time zero to the last
Measured: 48 hours after administration
AUC0-∞
area under the plasma concentration time curve from time zero to infinity
Measured: 48 hours after administration
AUC0-24h
area under the plasma concentration time curve from time zero to 24 hours
Measured: 48 hours after administration
Tmax
time at which Cmax occurs
Measured: 48 hours after administration
t1/2
half life of elimination
Measured: 48 hours after administration
CL/F
apparent clearance
Measured: 48 hours after administration
Vd/F
apparent volume of distribution during the terminal phase
Measured: 48 hours after administration
Ke
elimination rate constant
Measured: 48 hours after administration
MRT
mean Resident Time
Measured: 48 hours after administration
BP
Blood Plasma Ratio
Measured: 48 hours after administration
BRPP
binding rate of plasma protein
Measured: 48 hours after administration
Secondary outcomes (5)
structural of metabolites
Structure of main metabolites of LV232 in plasma, feces and urine
Measured: From time zero up to 96 hours post-dose following oral administration
Ae
Cumulative excretion of LV232 and major metabolites in feces and urine
Measured: From time zero up to 96 hours post-dose following oral administration
Fe%
Percentage of LV232 and major metabolites in feces and urine
Measured: From time zero up to 96 hours post-dose following oral administration
CLr
renal clearance rate
Measured: 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
Measured: Before administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start5 Oct 2023
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Yu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070857
- Sponsor's protocol ID
- LV232-01
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06070857
- Acronym / sponsor ID
- LV232-01
- Conditions
- Healthy Subjects
- Keywords
- LV232, Phase I, dose-escalation, Tolerability, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LV232 | Experimental | Drug: LV232Subjects will receive LV232 orally for single dose. |
| Placebo | Experimental | Drug: PlaceboSubjects will receive placebo orally for single dose. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LV232Drug: LV232 1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg | Drug | LV232 |
| PlaceboPlacebo:1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 7 days after treatment
Incidence of Treatment-Emergent Adverse Events
Cmax
Time frame: 48 hours after administration
maximum observed plasma concentration
AUC0-t
Time frame: 48 hours after administration
area under the plasma concentration time curve from time zero to the last
AUC0-∞
Time frame: 48 hours after administration
area under the plasma concentration time curve from time zero to infinity
AUC0-24h
Time frame: 48 hours after administration
area under the plasma concentration time curve from time zero to 24 hours
Tmax
Time frame: 48 hours after administration
time at which Cmax occurs
t1/2
Time frame: 48 hours after administration
half life of elimination
CL/F
Time frame: 48 hours after administration
apparent clearance
Vd/F
Time frame: 48 hours after administration
apparent volume of distribution during the terminal phase
Ke
Time frame: 48 hours after administration
elimination rate constant
MRT
Time frame: 48 hours after administration
mean Resident Time
BP
Time frame: 48 hours after administration
Blood Plasma Ratio
BRPP
Time frame: 48 hours after administration
binding rate of plasma protein
5 secondary outcomes
structural of metabolites
Time frame: From time zero up to 96 hours post-dose following oral administration
Ae
Time frame: From time zero up to 96 hours post-dose following oral administration
Fe%
Time frame: From time zero up to 96 hours post-dose following oral administration
CLr
Time frame: From time zero up to 72 hours post-dose following oral administration
Genetic polymorphisms in drug metabolism
Time frame: Before administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Yu principal investigator
Xuhui Central Hospital, Shanghai
1 site in 1 country: see every site and its status.
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 16 Dec 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?
Incidence of Treatment-Emergent Adverse Events (time frame: 7 days after treatment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.