Liver function study tests new Drug's safety in 24 volunteers
NCT ID NCT07551557
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times
Summary
This early-stage study looks at how a single 25 mg dose of VC005 tablets behaves in people with mild or moderate liver impairment compared to healthy volunteers. The goal is to measure drug levels and safety. 24 participants will take one dose and be monitored closely.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Apr 2026
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 2. 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; 3. Male and female participants aged 18 to 79 years (inclusive); 4. 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). Exclusion Criteria: 1. History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components; 2. 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; 3. 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; 4. 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; 5. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex; 6. 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; 7. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000, China
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Other studies related to the condition(s) this trial covers.
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