Subjects With Liver Function InjuryPhase 1NCT06093230
A Study in Subjects With Liver Function Injury and Subjects With Normal Liver Function
A Phase 1 study testing Deuremidevir Hydrobromide Tablets in people with Subjects With Liver Function Injury and Normal Liver Function Subject, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.
Trial summary
Evaluate the pharmacokinetic differences of the main metabolite 116-N1 of JT001 in subjects with mild and moderate liver function impairment and those with normal liver function, providing a basis for formulating clinical medication plans for patients with liver function impairment; Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With Liver Function Injury, Normal Liver Function Subject
- What is being tested?
- Deuremidevir Hydrobromide 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
- 28 Jul 2023to 18 Aug 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- On the day of signing the informed consent form, the age range is 18 to 70 years (including both ends), both male and female are eligible;
- Male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends), where BMI=weight (kg)/height 2 (m2);
- Subjects with normal liver function also need to meet all the following conditions:
- When screening, the following demographic matching criteria must be met:
- Match the weight with the liver function impairment group, with a mean of ± 10 kg;
- Age matched with the liver function impairment group, with a mean of ± 10 years;
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- Gender matching was performed with the liver function impairment group, with a mean of ± 1 case;
- Subjects with liver function impairment also need to meet all the following conditions:
- Patients with chronic liver injury caused by primary liver diseases (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) and stable liver function (without any liver disease related medical records within 14 days before taking the study drug, except for regular follow-up and medication) with liver dysfunction classified as A or B by Child-Pugh ;
- Clinically diagnosed as liver cirrhosis;
- Those who have a stable medication plan for the treatment of liver function damage, complications, and other accompanying diseases for at least 14 days before taking the study drug, and the medication does not need to be adjusted (including medication type, dosage, or frequency); Or those who have not taken medication;
- Estimated Glomerular filtration rate (eGFR, calculated using the CKD-EPI formula) ≥ 60 mL/min/1.73m2;
Who cannot join
- The electrocardiogram shows a QTc interval (QTcF) of>450 msec for males and>470 msec for females (corrected according to Fridericia's standard);
- Screening for individuals with severe infections, trauma, gastrointestinal surgery, or other major surgical procedures within the first 4 weeks;
- Those who have received the vaccine within 14 days before screening or plan to receive the vaccine during the study period;
- Those who donate blood or have a blood loss of ≥ 400 mL within the first 3 months of screening, or intend to donate blood during or within 1 month after the trial;
- Screening for potent inhibitors or inducers of Pg-P or BCRP that have been used within the previous month (see Attachment 4);
- Those who have taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (an average of 8 or more cups per day, 200 mL per cup) within 2 weeks before administration;
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- Screening for alcoholics within the first three months, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer, or 45 mL of 40% alcohol or 150 mL of wine) or those who are positive for alcohol screening;
- Individuals who smoke an average of 10 or more cigarettes per day within the first 3 months of screening;
- Subjects with normal liver function who meet any of the following exclusion criteria need to be excluded:
- History of liver injury;
- Individuals who have previously or currently suffered from any clinical serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that may interfere with the test results;
- Abnormalities in physical examination, vital signs, laboratory examination, 12 lead electrocardiogram, abdominal ultrasound, and other examinations have been determined by the researcher to have clinical significance;
- Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antigen/antibody or syphilis antibody;
- Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or supplements within 14 days prior to the administration of the study drug;
- Subjects with liver function impairment who meet any of the following exclusion criteria need to be excluded:
- The subject has any of the following conditions: drug-induced liver injury; History of liver transplantation; And researchers believe that liver cirrhosis
- During screening, the laboratory test results meet any of the following criteria: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>5 × ULN; (b) Absolute value of neutrophils (NE #)<1 × 109/L; (c) Hemoglobin (HGB)<80 g/L; (d) Alpha fetoprotein (AFP)>100 ng/mL;
- Except for the primary liver disease itself, those who have previously or currently suffered from other serious organ system diseases, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, tumor, immune, mental, or cardiovascular diseases or clinical laboratory examination abnormalities, which have clinical significance, and are determined by the research doctor to be unsuitable for participating in this trial;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University Ethics Committee
Changchun, Jilin, 130021
About this study
Official title: An Open-label, Single-dose, Phase I Study to Assess the Pharmacokinetics and Safety of JT001 in Subjects With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Evaluate the pharmacokinetic differences of the main metabolite 116-N1 of JT001 in subjects with mild and moderate liver function impairment and those with normal liver function, providing a basis for formulating clinical medication plans for patients with liver function impairment;
Read the detailed description
This study adopts a non randomized, open, parallel controlled, single dose experimental design and is divided into three experimental groups: mild liver function impairment group (Group A), moderate liver function impairment group (Group B), and normal liver function subject group (Group C). Subjects in each experimental group took 0.3g of JT001 orally on an empty stomach and collected blood samples before and after administration for pharmacokinetic analysis.
After both groups A and B were enrolled, Group C subjects will be enrolled subsequently and should be matched with subjects with liver function impairment (Group A and Group B) as following:
The average body weight of Group C is within ± 10 kg of the average body weight of the group of subjects with liver function impairment (Groups A and B).
The average age of Group C is within ± 10 years of the average age of the group of subjects with liver function impairment (Groups A and B).
The number of subjects of each gender in Group C is similar to that in the liver function impairment group (A and B groups) (± 1 subject/gender).
The study is divided into three stages: screening period, baseline period, and experimental period.
- Being tested
- Deuremidevir Hydrobromide Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuremidevir Hydrobromide TabletsDrug
Also called JT001
JT001 single dose, 0.3g
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | mild liver function impairment group Receives: Drug: Deuremidevir Hydrobromide Tablets |
| Group B | Experimental | moderate liver function impairment group Receives: Drug: Deuremidevir Hydrobromide Tablets |
| Group C | Experimental | normal liver function subject group Receives: Drug: Deuremidevir Hydrobromide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cmax of the main metabolite 116-N1 of JT001;
maximum observed plasma concentration
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
The AUC0-t of the main metabolite 116-N1 of JT001;
area under the curve from time zero to the last measurable concentration
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
The AUC0-inf of the main metabolite 116-N1 of JT001;
area under curve from time zero to infinity
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
Tmax of the main metabolite 116-N1 of JT001;
Time to maximum observed concentration of the main metabolite 116-N1 of JT001;
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
t1/2 of the main metabolite 116-N1 of JT001;
Terminal phase half-life of the main metabolite 116-N1 of JT001;
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
CL/F of the main metabolite 116-N1 of JT001;
The clearance of the main metabolite 116-N1 of JT001;
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
Vz/F of the main metabolite 116-N1 of JT001;
The apparent volume of distribution of the main metabolite 116-N1 of JT001;
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
The severity of SAE
The severity of SAE
Measured: From Day 1(first dose) to Day7
The Number of participants with SAE
The Number of participants with SAE
Measured: From Day 1(first dose) to Day7
The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
Measured: From Day 1(first dose) to Day7
The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
Measured: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of Pulse abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal Pulse
Measured: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of blood pressure abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal blood pressure
Measured: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of respiration abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal respiration
Measured: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of body temperature abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal body temperature
Measured: From Day 1(first dose) to Day7
The severity of abnormal physical examinations findings
The severity of abnormal physical examinations findings
Measured: From Day 1(first dose) to Day7
The Number of participantswith abnormal physical examinations findings
The Number of participantswith abnormal physical examinations findings
Measured: From Day 1(first dose) to Day7
The severity of abnormal laboratory tests results
The severity of abnormal laboratory tests results
Measured: From Day 1(first dose) to Day7
The Number of participantswith abnormal laboratory tests results
The Number of participantswith abnormal laboratory tests results
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of Heart rate abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with Heart rate abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of PR interval abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with PR interval abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QRS interval abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QRS interval abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QT interval abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QT interval abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QTcF abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QTcF abnormalities
Measured: From Day 1(first dose) to Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start28 Jul 2023
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjects With Liver Function InjuryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Huiyu Lan, Project Director, Study director, Shanghai Vinnerna Biosciences Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093230
- Sponsor's protocol ID
- JT001-007-I
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Tan X, Lu T, Kuang S, Meng Q, Yu G, Zou J, Wang Y. Pharmacokinetics and Safety of VV116 in Subjects With Mild or Moderate Hepatic Impairment Compared With Healthy Controls: A Phase I, Open-Label Study. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e70037. doi: 10.1002/cpdd.70037.
PubMed 41733177
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Phase I Study to Assess the Pharmacokinetics and Safety of JT001 in Subjects With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06093230
- Acronym / sponsor ID
- JT001-007-I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 23 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.
Evaluate the pharmacokinetic differences of the main metabolite 116-N1 of JT001 in subjects with mild and moderate liver function impairment and those with normal liver function, providing a basis for formulating clinical medication plans for patients with liver function impairment;
Detailed description
This study adopts a non randomized, open, parallel controlled, single dose experimental design and is divided into three experimental groups: mild liver function impairment group (Group A), moderate liver function impairment group (Group B), and normal liver function subject group (Group C). Subjects in each experimental group took 0.3g of JT001 orally on an empty stomach and collected blood samples before and after administration for pharmacokinetic analysis.
After both groups A and B were enrolled, Group C subjects will be enrolled subsequently and should be matched with subjects with liver function impairment (Group A and Group B) as following:
The average body weight of Group C is within ± 10 kg of the average body weight of the group of subjects with liver function impairment (Groups A and B).
The average age of Group C is within ± 10 years of the average age of the group of subjects with liver function impairment (Groups A and B).
The number of subjects of each gender in Group C is similar to that in the liver function impairment group (A and B groups) (± 1 subject/gender).
The study is divided into three stages: screening period, baseline period, and experimental period.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Deuremidevir Hydrobromide Tabletsmild liver function impairment group |
| Group B | Experimental | Drug: Deuremidevir Hydrobromide Tabletsmoderate liver function impairment group |
| Group C | Experimental | Drug: Deuremidevir Hydrobromide Tabletsnormal liver function subject group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- On the day of signing the informed consent form, the age range is 18 to 70 years (including both ends), both male and female are eligible;
- Male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends), where BMI=weight (kg)/height 2 (m2);
- When screening, the following demographic matching criteria must be met:
- Patients with chronic liver injury caused by primary liver diseases (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) and stable liver function (without any liver disease related medical records within 14 days before taking the study drug, except for regular follow-up and medication) with liver dysfunction classified as A or B by Child-Pugh ;
- Clinically diagnosed as liver cirrhosis;
Key exclusion criteria (18 listed)
- The electrocardiogram shows a QTc interval (QTcF) of>450 msec for males and>470 msec for females (corrected according to Fridericia's standard);
- Screening for individuals with severe infections, trauma, gastrointestinal surgery, or other major surgical procedures within the first 4 weeks;
- Those who have received the vaccine within 14 days before screening or plan to receive the vaccine during the study period;
- Those who donate blood or have a blood loss of ≥ 400 mL within the first 3 months of screening, or intend to donate blood during or within 1 month after the trial;
- Screening for potent inhibitors or inducers of Pg-P or BCRP that have been used within the previous month (see Attachment 4);
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 |
|---|---|---|
| Deuremidevir Hydrobromide TabletsAlso: JT001JT001 single dose, 0.3g | Drug | Group A, Group B, Group C |
Primary outcome
The Cmax of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
maximum observed plasma concentration
The AUC0-t of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
area under the curve from time zero to the last measurable concentration
The AUC0-inf of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
area under curve from time zero to infinity
Tmax of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Time to maximum observed concentration of the main metabolite 116-N1 of JT001;
t1/2 of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Terminal phase half-life of the main metabolite 116-N1 of JT001;
CL/F of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
The clearance of the main metabolite 116-N1 of JT001;
Vz/F of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
The apparent volume of distribution of the main metabolite 116-N1 of JT001;
The severity of SAE
Time frame: From Day 1(first dose) to Day7
The severity of SAE
The Number of participants with SAE
Time frame: From Day 1(first dose) to Day7
The Number of participants with SAE
The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
Time frame: From Day 1(first dose) to Day7
The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of Pulse abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal Pulse
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of blood pressure abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal blood pressure
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of respiration abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal respiration
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of body temperature abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal body temperature
The severity of abnormal physical examinations findings
Time frame: From Day 1(first dose) to Day7
The severity of abnormal physical examinations findings
The Number of participantswith abnormal physical examinations findings
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal physical examinations findings
The severity of abnormal laboratory tests results
Time frame: From Day 1(first dose) to Day7
The severity of abnormal laboratory tests results
The Number of participantswith abnormal laboratory tests results
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal laboratory tests results
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of Heart rate abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with Heart rate abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of PR interval abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with PR interval abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of QRS interval abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with QRS interval abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of QT interval abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with QT interval abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of QTcF abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with QTcF abnormalities
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 23 Oct 2023.
- Derived from this study: PubMed 41733177Tan X, Lu T, Kuang S, Meng Q, Yu G, Zou J, Wang Y. Pharmacokinetics and Safety of VV116 in Subjects With Mild or Moderate Hepatic Impairment Compared With Healthy Controls: A Phase I, Open-Label Study. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e70037. doi: 10.1002/cpdd.70037.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Huiyu Lan, Project Director study director
Shanghai Vinnerna Biosciences Co., Ltd.
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 Deuremidevir Hydrobromide Tablets in people with Subjects With Liver Function Injury and Normal Liver Function Subject, run by Shanghai Vinnerna Biosciences 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 12 inclusion and 18 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 23 Oct 2023. 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?
The Cmax of the main metabolite 116-N1 of JT001; (time frame: From time zero up to 72 hours post-dose following oral administration of JT001). The study lists 33 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 NCT06093230, which also lists 1 linked publication.
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 23 Oct 2023.