Liver FibrosisPhase 1NCT07394309
Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls
A Phase 1 study testing Hydronidone capsules in people with Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Hydronidone capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 11 May 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for enrollment:
- Participants fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process as required by the protocol.
- Age between 18 and 75 years (inclusive), both males and females.
- At screening, male participants weigh ≥50 kg, female participants weigh ≥45 kg, and body mass index [BMI = weight (kg) / height² (m²)] is within the range of 18 to 32 kg/m² (inclusive).
- Participants and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent form until 6 months after the last dose of the investigational drug, and voluntarily agree to use effective contraceptive measures.
- Participants with hepatic impairment must additionally meet the following inclusion criteria:
- Participants with hepatic impairment due to pre-existing primary liver disease, classified as Child-Pugh Class A (score of 5-6) or Class B (score of 7-9) at screening. They must not have received albumin infusion within 14 days prior to screening and must have a confirmed diagnosis of stable (≥1 month) hepatic impairment based on medical history, physical examination, laboratory tests, or imaging studies.
- Participants have not taken any medication within 1 week prior to screening, or for those requiring long-term treatment for hepatic impairment and/or other comorbidities, their medication regimen must have been stable for at least 4 weeks (stability is judged by the investigator, excluding medications prohibited by the protocol).
Who cannot join
- Known history of allergy to any component of the investigational product, drugs of the same class (GLP-1 receptor agonists), or their excipients; or history of allergic constitution (multiple drug and food allergies); or history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.).
- Diagnosis of malignant tumor, or history of malignant tumor within 5 years prior to screening (except for: prior hepatocellular carcinoma surgery with stability ≥2 years; treated non-melanoma skin cancer with no signs of recurrence; and excised cervical intraepithelial neoplasia).
- Presence of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening.
- 12-lead electrocardiogram (ECG) abnormalities considered clinically significant by the investigator [e.g., tachycardia/bradycardia requiring medication, II-III degree atrioventricular block, prolonged QTcF interval (male QTcF >470 ms, female QTcF >480 ms, corrected using Fridericia's formula), or other abnormalities deemed clinically significant by the physician].
- Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula <60 mL/min/1.73 m².
- Planned surgical procedure or hospitalization tendency during the trial period.
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- Positive for HIV antibody (HIV-Ab) or Treponema pallidum (TP) antibody.
- Use of inducers or inhibitors of drug-metabolizing enzymes (CYP3A4 inducers and inhibitors, detailed list in Appendix 4: Common Drugs that are Inhibitors or Inducers of Drug-Metabolizing Enzymes) within 4 weeks prior to dosing.
- Use of drugs known to inhibit or induce SULT and UGT enzymes within 7 days prior to investigational drug administration, and inability to discontinue such use.
- Use of any medication (including herbal medicines, vitamins, health supplements) within 14 days (or 5 half-lives, whichever is longer) prior to dosing, except for stable medications in participants with hepatic impairment.
- Participation in another clinical trial and receipt of an investigational drug or medical device within 1 month prior to screening, with the last dose date of the previous clinical study as the reference point (if the previous investigational drug has a long half-life, at least 5 half-lives must elapse before dosing in this study).
- History of blood loss or blood donation ≥400 mL within 3 months prior to dosing, or plans to donate blood within 1 month after the end of this trial.
- History of smoking or smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from any tobacco products during the study, or positive nicotine test at baseline.
- Regular alcohol consumption at present or within 1 month prior to screening, defined as females consuming more than 7 units of alcohol per week or males consuming more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits with 40% alcohol, or 100 mL of wine); or positive alcohol breath test at baseline, or inability to abstain from alcohol during the trial.
- History of drug abuse, or use of soft drugs (e.g., marijuana) within 3 months prior to dosing, or use of hard drugs (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year prior to dosing, or positive drug abuse screening at baseline.
- Consumption of food or beverages containing grapefruit juice/pomelo juice or methylxanthines (tea, coffee, cola, chocolate, energy drinks) within 48 hours prior to dosing, or consumption of any other substance that may affect drug absorption, distribution, metabolism, or excretion.
- Intolerance to venipuncture, history of needle phobia, or fainting at the sight of blood.
- Vaccination within 1 month prior to screening.
- Women who are pregnant or breastfeeding, or participants with a positive blood pregnancy test.
- Participants considered by the investigator to have poor compliance or other factors unsuitable for participation in this trial.
- Supplementary Exclusion Criteria for Participants with Hepatic Impairment (Exclusion if any one of the following criteria is met):
- History of liver transplantation.
- Drug-induced liver injury.
- Acute liver injury due to any cause.
- Cholestatic liver disease.
- Liver failure with any of the following complications: uncontrolled infection; grade 3/4 hepatic encephalopathy.
- Severe complications of cirrhosis with any of the following: active bleeding from esophageal or gastric varices; severe/advanced ascites or pleural effusion requiring paracentesis or drainage and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.
- Participants with poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg) or heart rate >120 bpm (allow two repeat measurements).
- Any history of severe disease other than the primary liver disease itself, or any medical history or clinically significant abnormal laboratory findings considered by the investigator as likely to affect the trial results, including but not limited to history of circulatory, endocrine, neurological, digestive, urinary, hematological, immunological, psychiatric, or metabolic disorders.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) at screening.
- Supplementary Exclusion Criteria for Participants with Normal Hepatic Function (Exclusion if any one of the following criteria is met):
- Positive for anti-hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg).
- History of primary disease of vital organs, including but not limited to neurological/psychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, or immune system diseases, deemed by the investigator as unsuitable for trial participation.
- History of hepatic impairment, or any screening examination results (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, 12-lead ECG, chest X-ray posteroanterior view, abdominal ultrasound, etc.) considered by the investigator as clinically significant abnormalities.
- Age not within the range of the mean age of participants with mild/moderate hepatic impairment ±10 years, and/or BMI not within the range of the mean BMI of participants with mild/moderate hepatic impairment ±10%.
- -Supplementary Exclusion Criteria for Participants with Normal Hepatic Function (Exclusion if any one of the following criteria is met):
- Positive for anti-hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg).
- History of primary disease of vital organs, including but not limited to neurological/psychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, or immune system diseases, deemed by the investigator as unsuitable for trial participation.
- History of hepatic impairment, or any screening examination results (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, 12-lead ECG, chest X-ray posteroanterior view, abdominal ultrasound, etc.) considered by the investigator as clinically significant abnormalities.
- Age not within the range of the mean age of participants with mild/moderate hepatic impairment ±10 years, and/or BMI not within the range of the mean BMI of participants with mild/moderate hepatic impairment ±10%.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
About this study
Official title: A Phase I Pharmacokinetic Study of Hydronidone Capsules in Patients With Varying Degrees of Hepatic Impairment and Normal Hepatic Function.
This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. The administration method is a single oral dose of 90 mg hydroxynidone capsules under fasting conditions.
Participants meeting the inclusion criteria with corresponding degrees of hepatic impairment and those with normal hepatic function will be enrolled. Each group will complete the study with 10 participants. Matched participants will be comparable in terms of sex (±1 participant per sex), mean age (±10 years), and mean BMI (±10%).
- Conditions
- Liver Fibrosis
- Being tested
- Hydronidone capsules
- Keywords
- Hydronidone, Liver Fibrosis, Patients with hepatic fibrosis due to chronic hepatitis B
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone capsulesDrug
A single oral dose of 90 mg of the investigational drug (3 Hydronidone capsules) under fasting conditions, administered with 240 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| Group One A(mild hepatic impairment group) | Experimental | 10 participants with mild hepatic impairment (Child-Pugh A, score 5-6). Receives: Drug: Hydronidone capsules |
| Group Two B(moderate hepatic impairment group) | Experimental | 10 participants with moderate hepatic impairment (Child-Pugh Class B, score of 7-9). Receives: Drug: Hydronidone capsules |
| Group Three C（control group, normal hepatic function group） | Experimental | Matched 10 healthy participants with normal hepatic function will serve as the control group. Receives: Drug: Hydronidone capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter of Hydronidone: Cmax
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone: AUC0-t
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:AUC0-∞
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Tmax
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:t1/2
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:λz
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:CL/F
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:MRT
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Vz/F
Measured: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Ratio of free drugsRatio of free drugs
Measured: Within 48 hours of administration
Difference in the main parameters AUC₀-t between patients with hepatic impairment and participants with normal hepatic function.
Measured: Within 48 hours of administration
Difference in the main parameters AUC₀-∞ between patients with hepatic impairment and participants with normal hepatic function.
Measured: Within 48 hours of administration
Difference in the main parameters Cmax between patients with hepatic impairment and participants with normal hepatic function.
Measured: Within 48 hours of administration
Secondary outcomes (6)
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: Cmax (Metabolic Ratio).
Measured: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-t, (Metabolic Ratio).
Measured: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: MR (Metabolic Ratio).
Measured: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-∞, (Metabolic Ratio).
Measured: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 andM4:Tmax(Metabolic Ratio).
Measured: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: t₁/₂(Metabolic Ratio).
Measured: Within 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start25 Mar 2026
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394309
- Sponsor's protocol ID
- KDN-F351-202507
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2026
- Last updated
- 13 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacokinetic Study of Hydronidone Capsules in Patients With Varying Degrees of Hepatic Impairment and Normal Hepatic Function.
- ClinicalTrials.gov ID
- NCT07394309
- Acronym / sponsor ID
- KDN-F351-202507
- Conditions
- Liver Fibrosis
- Keywords
- Hydronidone, Liver Fibrosis, Patients with hepatic fibrosis due to chronic hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 6 Feb 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 trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. The administration method is a single oral dose of 90 mg hydroxynidone capsules under fasting conditions.
Participants meeting the inclusion criteria with corresponding degrees of hepatic impairment and those with normal hepatic function will be enrolled. Each group will complete the study with 10 participants. Matched participants will be comparable in terms of sex (±1 participant per sex), mean age (±10 years), and mean BMI (±10%).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group One A(mild hepatic impairment group) | Experimental | Drug: Hydronidone capsules10 participants with mild hepatic impairment (Child-Pugh A, score 5-6). |
| Group Two B(moderate hepatic impairment group) | Experimental | Drug: Hydronidone capsules10 participants with moderate hepatic impairment (Child-Pugh Class B, score of 7-9). |
| Group Three C（control group, normal hepatic function group） | Experimental | Drug: Hydronidone capsulesMatched 10 healthy participants with normal hepatic function will serve as the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must meet all of the following criteria to be eligible for enrollment:
- Participants fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process as required by the protocol.
- Age between 18 and 75 years (inclusive), both males and females.
- At screening, male participants weigh ≥50 kg, female participants weigh ≥45 kg, and body mass index [BMI = weight (kg) / height² (m²)] is within the range of 18 to 32 kg/m² (inclusive).
- Participants and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent form until 6 months after the last dose of the investigational drug, and voluntarily agree to use effective contraceptive measures.
Key exclusion criteria (40 listed)
- Known history of allergy to any component of the investigational product, drugs of the same class (GLP-1 receptor agonists), or their excipients; or history of allergic constitution (multiple drug and food allergies); or history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.).
- Diagnosis of malignant tumor, or history of malignant tumor within 5 years prior to screening (except for: prior hepatocellular carcinoma surgery with stability ≥2 years; treated non-melanoma skin cancer with no signs of recurrence; and excised cervical intraepithelial neoplasia).
- Presence of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening.
- 12-lead electrocardiogram (ECG) abnormalities considered clinically significant by the investigator [e.g., tachycardia/bradycardia requiring medication, II-III degree atrioventricular block, prolonged QTcF interval (male QTcF >470 ms, female QTcF >480 ms, corrected using Fridericia's formula), or other abnormalities deemed clinically significant by the physician].
- Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula <60 mL/min/1.73 m².
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 |
|---|---|---|
| Hydronidone capsulesA single oral dose of 90 mg of the investigational drug (3 Hydronidone capsules) under fasting conditions, administered with 240 mL of water. | Drug | Group One A(mild hepatic impairment group), Group Three C（control group, normal hepatic function group）, Group Two B(moderate hepatic impairment group) |
Primary outcome
Pharmacokinetic Parameter of Hydronidone: Cmax
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone: AUC0-t
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:AUC0-∞
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Tmax
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:t1/2
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:λz
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:CL/F
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:MRT
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Vz/F
Time frame: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Ratio of free drugsRatio of free drugs
Time frame: Within 48 hours of administration
Difference in the main parameters AUC₀-t between patients with hepatic impairment and participants with normal hepatic function.
Time frame: Within 48 hours of administration
Difference in the main parameters AUC₀-∞ between patients with hepatic impairment and participants with normal hepatic function.
Time frame: Within 48 hours of administration
Difference in the main parameters Cmax between patients with hepatic impairment and participants with normal hepatic function.
Time frame: Within 48 hours of administration
6 secondary outcomes
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: Cmax (Metabolic Ratio).
Time frame: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-t, (Metabolic Ratio).
Time frame: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: MR (Metabolic Ratio).
Time frame: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-∞, (Metabolic Ratio).
Time frame: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 andM4:Tmax(Metabolic Ratio).
Time frame: Within 48 hours after administration
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: t₁/₂(Metabolic Ratio).
Time frame: Within 48 hours after 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 13 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hydronidone capsules in people with Liver Fibrosis, run by Beijing Continent Pharmaceutical 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 8 inclusion and 40 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 13 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?
Pharmacokinetic Parameter of Hydronidone: Cmax (time frame: Within 48 hours of administration). 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 13 Aug 2026.