Liver FibrosisPhase 1NCT07262346
The Phase Ⅰd Clinical Trial of Hydronidone Capsules
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
Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. Read more about this study
- Who is it for?
- Ages 18 to 45 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?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2025to 28 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, both male and female;
- Age: 18-45 years;
- Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)/height² (m²));
- Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;
- Have been fully informed about the nature, significance, potential benefits, possible inconveniences, and risks of the study prior to participation, and voluntarily agree to take part in this clinical trial. Subjects must be able to communicate well with the researchers, comply with all study requirements, and have the capacity to understand and sign the written informed consent form.
Who cannot join
- (Inquiry) Participation in any other clinical trial within three months prior to this study;
- (Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders [particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.];
- (Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;
- (Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);
- Use of any medications (including herbal medicines) or health products within 14 days before the first dose;
- (Inquiry) Individuals with special dietary requirements who cannot adhere to a standardized diet (e.g., intolerance to standard meals) or those with difficulty swallowing;
Show all 22Show fewer
- (Inquiry) Inability to tolerate venipuncture and/or a history of blood or needle phobia;
- (Inquiry) Habitual excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL); or consumption of any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) within 48 hours before the first dose, or adherence to any special diet that may affect drug absorption, distribution, metabolism, or excretion;
- (Inquiry) History of excessive alcohol consumption (defined as more than 28 standard units per week for men and more than 21 standard units per week for women (1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine)); or regular alcohol consumption (more than 14 standard units per week) within 6 months prior to the trial; or consumption of any alcohol-containing products within 24 hours before the first dose;
- (Inquiry) Blood donation or significant blood loss (exceeding 450 mL) within 3 months before the first dose, or plans to donate blood or blood components during the study or within 3 months after its completion;
- (Inquiry) Occurrence of an acute illness during the pre-study screening phase or before administration of the study drug;
- (Inquiry) Consumption of any foods or beverages known to induce or inhibit hepatic metabolic enzymes (e.g., grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which are rich in flavonoids or citrus glycosides) within 24 hours before the first dose;
- (Inquiry) Surgery within three months before screening or plans to undergo surgery during the study period;
- (Inquiry) History of drug abuse or substance abuse;
- (Inquiry) Smoking more than 5 cigarettes per day within 14 days before screening, or inability to discontinue the use of any tobacco products during the trial period;
- (Inquiry) Smoking or use of any tobacco products between screening and hospital admission;
- Positive nicotine test result;
- Alcohol breath test result greater than 0.0 mg/100 mL;
- Positive urine drug screen result;
- Pregnant or breastfeeding women;
- Individuals planning to conceive within 6 months after the trial or unwilling to use non-pharmacological contraceptive measures;
- Any condition deemed by the investigator as potentially affecting the subject's ability to provide informed consent, comply with the trial protocol, or participate in the trial in a way that could impact the results or subject safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)
Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.
- Conditions
- Liver Fibrosis
- Being tested
- Hydronidone capsules, Placebo capsules
- Keywords
- Hydronidone
- 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
SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs
Placebo capsulesDrug
SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs
| Study group | Role | What they receive |
|---|---|---|
| SAD:180mg drug group | Experimental | On the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once. Receives: Drug: Hydronidone capsules |
| SAD:120mg drug group | Experimental | On the morning of D1, the patients took 120mg of hydronidone capsules orally on an empty stomach once. Receives: Drug: Hydronidone capsules |
| SAD:240mg drug group | Experimental | On the morning of D1, the patients took 240mg of hydronidone capsules orally on an empty stomach once. Receives: Drug: Hydronidone capsules |
| SAD:300mg drug group | Experimental | On the morning of D1, the patients took 300mg of hydronidone capsules orally on an empty stomach once. Receives: Drug: Hydronidone capsules |
| SAD:360mg drug group | Experimental | On the morning of D1, the patients took 360mg of hydronidone capsules orally on an empty stomach once. Receives: Drug: Hydronidone capsules |
| SAD:420mg drug group | Experimental | On the morning of D1, the patients took 420mg of hydronidone capsules orally on an empty stomach once. Receives: Drug: Hydronidone capsules |
| MAD: drug group1 (dosage to be determined) | Experimental | Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. Receives: Drug: Hydronidone capsules |
| MAD: drug group 2 (dosage to be determined) | Experimental | Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. Receives: Drug: Hydronidone capsules |
| MAD: drug group 3 (dosage to be determined) | Experimental | Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. Receives: Drug: Hydronidone capsules |
| Study on the Interaction between Food and Drugs:drug group1 (dosage to be determined) | Experimental | Period 1 involved administration under fasting conditions, with a 7-day washout period starting on Day 2. Administration for Period 2 was conducted on Day 8. Receives: Drug: Hydronidone capsules |
| Study on the Interaction between Food and Drugs:drug group2 (dosage to be determined) | Experimental | In Period 1, a high-fat meal was consumed first, followed by drug administration within 30 minutes, with washout commencing on Day 2. After a total 7-day washout period, the second period of dosing was administered on Day 8. Receives: Drug: Hydronidone capsules |
| SAD:Placebo group | Placebo comparator | On the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once. Receives: Drug: Placebo capsules |
| MAD:Placebo group | Placebo comparator | Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD :Blood drug PK parameters(Cmax)
Measured: 24 hours after administration
SAD:Blood drug PK parameters（Tmax）
Measured: 24 hours after administration
SAD:Blood drug PK parameters（AUC0-t）
Measured: 24 hours after administration
SAD:Blood drug PK parameters( t1/2)
Measured: 24 hours after administration
SAD:Blood drug PK parameters(AUC0-∞)
Measured: 24 hours after administration
SAD:Blood drug PK parameters(λz)
Measured: 24 hours after administration
SAD:Blood drug PK parameters(Vd/F)
Measured: 24 hours after administration
SAD:Blood drug PK parameters(CL/F)
Measured: 24 hours after administration
SAD:Blood drug PK parameters(AUC_%Extrap)
Measured: 24 hours after administration
SAD:Blood drug PK parameters(MRT)
Measured: 24 hours after administration
MAD:Blood drug PK parameters(ss)
Measured: 24 hours after administration
MAD :Blood drug PK parameters(Cmax)
Measured: 24 hours after administration
MAD:Blood drug PK parameters（Tmax）
Measured: 24 hours after administration
MAD:Blood drug PK parameters（AUC0-t）
Measured: 24 hours after administration
MAD:Blood drug PK parameters( t1/2)
Measured: 24 hours after administration
MAD:Blood drug PK parameters(AUC0-∞)
Measured: 24 hours after administration
MAD:Blood drug PK parameters(λz)
Measured: 24 hours after administration
MAD:Blood drug PK parameters(Vd/F)
Measured: 24 hours after administration
MAD:Blood drug PK parameters(CL/F)
Measured: 24 hours after administration
MAD:Blood drug PK parameters(AUC_%Extrap)
Measured: 24 hours after administration
MAD:Blood drug PK parameters(MRT)
Measured: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(Tlag)
Measured: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(Cmax)
Measured: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(Tmax)
Measured: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(AUC0-t)
Measured: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(AUC0-∞)
Measured: 24 hours after administration
Secondary outcomes (5)
Hydronidone and its metabolites M3 and M4 blood drug concentrations (SAD)
Measured: 24 hours after administration
Hydronidone and its metabolites M3 and M4 blood drug concentrations (MAD)
Measured: 24 hours after administration
Safety indicator: Any adverse event
Adverse Event (AE) is defined as any untoward medical occurrence during drug clinical trials, drug therapy, or medical procedures, regardless of its causal relationship to the drug used.
Measured: 48 hours after administration
Safety indicators:Chest X-ray examination
Measured: 48 hours after administration
Safety indicators:12-lead electrocardiogram examination.
The 12-lead electrocardiogram records the electrical activity of the heart through 12 different lead positions, and is the most commonly used and fundamental non-invasive examination method for diagnosing heart diseases.A 12-lead ECG examines P waves, PR intervals, QRS complexes, ST segments, T waves, QT intervals, and other ECG waves and intervals.
Measured: 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 posted3 Dec 2025
- Study start24 Dec 2025
- Primary completion28 May 2026
- Study completion28 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262346
- Sponsor's protocol ID
- KDN-F351-202502
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 21 Sep 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)
- ClinicalTrials.gov ID
- NCT07262346
- Acronym / sponsor ID
- KDN-F351-202502
- Conditions
- Liver Fibrosis
- Keywords
- Hydronidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 3 Dec 2025 (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.
Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| SAD:180mg drug group | Experimental | Drug: Hydronidone capsulesOn the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once. |
| SAD:120mg drug group | Experimental | Drug: Hydronidone capsulesOn the morning of D1, the patients took 120mg of hydronidone capsules orally on an empty stomach once. |
| SAD:240mg drug group | Experimental | Drug: Hydronidone capsulesOn the morning of D1, the patients took 240mg of hydronidone capsules orally on an empty stomach once. |
| SAD:300mg drug group | Experimental | Drug: Hydronidone capsulesOn the morning of D1, the patients took 300mg of hydronidone capsules orally on an empty stomach once. |
| SAD:360mg drug group | Experimental | Drug: Hydronidone capsulesOn the morning of D1, the patients took 360mg of hydronidone capsules orally on an empty stomach once. |
| SAD:420mg drug group | Experimental | Drug: Hydronidone capsulesOn the morning of D1, the patients took 420mg of hydronidone capsules orally on an empty stomach once. |
| MAD: drug group1 (dosage to be determined) | Experimental | Drug: Hydronidone capsulesSingle dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. |
| MAD: drug group 2 (dosage to be determined) | Experimental | Drug: Hydronidone capsulesSingle dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. |
| MAD: drug group 3 (dosage to be determined) | Experimental | Drug: Hydronidone capsulesSingle dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. |
| Study on the Interaction between Food and Drugs:drug group1 (dosage to be determined) | Experimental | Drug: Hydronidone capsulesPeriod 1 involved administration under fasting conditions, with a 7-day washout period starting on Day 2. Administration for Period 2 was conducted on Day 8. |
| Study on the Interaction between Food and Drugs:drug group2 (dosage to be determined) | Experimental | Drug: Hydronidone capsulesIn Period 1, a high-fat meal was consumed first, followed by drug administration within 30 minutes, with washout commencing on Day 2. After a total 7-day washout period, the second period of dosing was administered on Day 8. |
| SAD:Placebo group | Placebo comparator | Drug: Placebo capsulesOn the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once. |
| MAD:Placebo group | Placebo comparator | Drug: Placebo capsulesSingle dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects, both male and female;
- Age: 18-45 years;
- Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)/height² (m²));
- Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;
- Have been fully informed about the nature, significance, potential benefits, possible inconveniences, and risks of the study prior to participation, and voluntarily agree to take part in this clinical trial. Subjects must be able to communicate well with the researchers, comply with all study requirements, and have the capacity to understand and sign the written informed consent form.
Key exclusion criteria (22 listed)
- (Inquiry) Participation in any other clinical trial within three months prior to this study;
- (Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders [particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.];
- (Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;
- (Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);
- Use of any medications (including herbal medicines) or health products within 14 days before the first dose;
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 capsulesSAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs | Drug | MAD: drug group 2 (dosage to be determined), MAD: drug group 3 (dosage to be determined), MAD: drug group1 (dosage to be determined), SAD:120mg drug group, SAD:180mg drug group, SAD:240mg drug group, SAD:300mg drug group, SAD:360mg drug group, SAD:420mg drug group, Study on the Interaction between Food and Drugs:drug group1 (dosage to be determined), Study on the Interaction between Food and Drugs:drug group2 (dosage to be determined) |
| Placebo capsulesSAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs | Drug | MAD:Placebo group, SAD:Placebo group |
Primary outcome
SAD :Blood drug PK parameters(Cmax)
Time frame: 24 hours after administration
SAD:Blood drug PK parameters（Tmax）
Time frame: 24 hours after administration
SAD:Blood drug PK parameters（AUC0-t）
Time frame: 24 hours after administration
SAD:Blood drug PK parameters( t1/2)
Time frame: 24 hours after administration
SAD:Blood drug PK parameters(AUC0-∞)
Time frame: 24 hours after administration
SAD:Blood drug PK parameters(λz)
Time frame: 24 hours after administration
SAD:Blood drug PK parameters(Vd/F)
Time frame: 24 hours after administration
SAD:Blood drug PK parameters(CL/F)
Time frame: 24 hours after administration
SAD:Blood drug PK parameters(AUC_%Extrap)
Time frame: 24 hours after administration
SAD:Blood drug PK parameters(MRT)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters(ss)
Time frame: 24 hours after administration
MAD :Blood drug PK parameters(Cmax)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters（Tmax）
Time frame: 24 hours after administration
MAD:Blood drug PK parameters（AUC0-t）
Time frame: 24 hours after administration
MAD:Blood drug PK parameters( t1/2)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters(AUC0-∞)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters(λz)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters(Vd/F)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters(CL/F)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters(AUC_%Extrap)
Time frame: 24 hours after administration
MAD:Blood drug PK parameters(MRT)
Time frame: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(Tlag)
Time frame: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(Cmax)
Time frame: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(Tmax)
Time frame: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(AUC0-t)
Time frame: 24 hours after administration
The influence of food on the parameters of single-dose pharmacokinetics(AUC0-∞)
Time frame: 24 hours after administration
5 secondary outcomes
Hydronidone and its metabolites M3 and M4 blood drug concentrations (SAD)
Time frame: 24 hours after administration
Hydronidone and its metabolites M3 and M4 blood drug concentrations (MAD)
Time frame: 24 hours after administration
Safety indicator: Any adverse event
Time frame: 48 hours after administration
Safety indicators:Chest X-ray examination
Time frame: 48 hours after administration
Safety indicators:12-lead electrocardiogram examination.
Time frame: 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 21 Sep 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 5 inclusion and 22 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 21 Sep 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. Some participants in this study may receive a placebo. 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?
SAD :Blood drug PK parameters(Cmax) (time frame: 24 hours after administration). The study lists 26 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 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.