Hepatic Impairment and Healthy FemalePhase 1NCT07551557
Pharmacokinetics of VC005 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study testing VC005 Tablets in people with Hepatic Impairment and Healthy Female, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with mild and moderate hepatic impairment compared to participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment and Healthy Female
- What is being tested?
- VC005 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2026to 14 Aug 2026
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements;
- Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs;
- Male and female participants aged 18 to 79 years (inclusive);
- Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg/m² (inclusive).
Who cannot join
- History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;
- History of drug abuse, drug addiction and/or alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening;
- Blood donation or significant blood loss (> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial; or use of albumin within 14 days before the first dose of the study drug;
- Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial;
- History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex;
- Known active bacterial, viral, fungal, parasitic infection or other infection, or any infectious event requiring antibiotic treatment or hospitalization (within 4 weeks prior to screening), or any acute infection within 2 weeks of baseline;
- History of dysphagia or, within 6 months prior to screening, any gastrointestinal conditions affecting drug absorption or excretion (e.g., reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), history of renal disease (confirmed renal disease regardless of cure; if only laboratory abnormalities such as elevated creatinine, hematuria, etc., to be assessed by the investigator), and history of surgery (e.g., gastrointestinal surgery and other major surgeries).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
About this study
This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with mild and moderate hepatic impairment compared to participants with normal hepatic function.
- Conditions
- Hepatic Impairment and Healthy Female
- Being tested
- VC005 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005 TabletsDrug
Oral single dose
| Study group | Role | What they receive |
|---|---|---|
| Normal Hepatic Function | Experimental | Not described Receives: Drug: VC005 Tablets |
| Mild Hepatic Impairment | Experimental | Not described Receives: Drug: VC005 Tablets |
| Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: VC005 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve(AUC）
Measured: Day1-Day3
Maximum Observed Plasma Concentration (Cmax)
Measured: Day1-Day3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start29 Apr 2026
- Primary completion2 Aug 2026
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Impairment and Healthy FemaleStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551557
- Sponsor's protocol ID
- VC005-108
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of VC005 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07551557
- Acronym / sponsor ID
- VC005-108
- Conditions
- Hepatic Impairment and Healthy Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 2 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 27 Apr 2026 (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.
This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with mild and moderate hepatic impairment compared to participants with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Hepatic Function | Experimental | Drug: VC005 Tablets |
| Mild Hepatic Impairment | Experimental | Drug: VC005 Tablets |
| Moderate Hepatic Impairment | Experimental | Drug: VC005 Tablets |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements;
- Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs;
- Male and female participants aged 18 to 79 years (inclusive);
- Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg/m² (inclusive).
Key exclusion criteria (7 listed)
- History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;
- History of drug abuse, drug addiction and/or alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening;
- Blood donation or significant blood loss (> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial; or use of albumin within 14 days before the first dose of the study drug;
- Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial;
- History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex;
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 |
|---|---|---|
| VC005 TabletsOral single dose | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function |
Primary outcome
Area under the plasma concentration-time curve(AUC）
Time frame: Day1-Day3
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day1-Day3
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 20 Aug 2026.
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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.
Huan Zhou principal investigator
The First Affiliated Hospital of Bengbu Medical University
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 VC005 Tablets in people with Hepatic Impairment and Healthy Female, run by Jiangsu vcare pharmaceutical technology co., LTD 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 4 inclusion and 7 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 20 Aug 2026. 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?
Area under the plasma concentration-time curve(AUC） (time frame: Day1-Day3). The study lists 2 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 20 Aug 2026.