Chronic Hepatitis B-related Liver FibrosisPhase 1NCT07471217
[¹⁴C] Hydronidone Mass Balance Study
A Phase 1 study testing [¹⁴C]Hydronidone in people with Chronic Hepatitis B-related Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B-related Liver Fibrosis
- What is being tested?
- [¹⁴C]Hydronidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2026to 6 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form;
- Chinese adult male participants aged 18 to 50 years (inclusive);
- Participants weighing at least 50 kg at screening, with a body mass index [BMI = weight (kg) / height² (m²)] within the range of 19.0 to 26.0 kg/m² (inclusive);
- Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner.
Who cannot join
- The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system;
- Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant;
- Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant;
- Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody;
- Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except for appendectomy), or plans to undergo surgery during the trial period;
- A previous diagnosis of Gilbert's syndrome;
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- Hemorrhoids with bloody stools or perianal diseases with regular or ongoing bloody stools; severe nausea or vomiting within one week before screening; habitual constipation or diarrhea; or positive fecal occult blood test;
- Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days or 5 half-lives (whichever is longer) prior to dosing; use of strong inhibitors or inducers of UGTs, SULTs, CYP3A4, P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1/3, or any drugs known to prolong the QT/QTc interval or carry a risk of causing torsade de pointes (TdP) within 4 weeks before screening (see Appendix 2 for details); or plans to use any chemical drugs, biologics, traditional Chinese medicines, or natural products during the trial that the researcher deems unsuitable;
- A history of drug allergies or allergic diseases (such as asthma, urticaria, eczematous dermatitis), or a suspected or confirmed allergy to the trial drug (including similar drugs) or any of its excipients as determined by the researcher;
- Participants with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;
- Participation in any other clinical trial drug or interventional clinical study within 3 months before screening;
- Blood donation or blood loss ≥ 400 mL within 3 months before dosing, or blood transfusion or use of blood products within 4 weeks before dosing;
- Difficulty in blood collection or intolerance to venous blood sampling.
- Individuals who work with long-term exposure to radioactive conditions, or those with significant radioactive exposure within 1 year prior to screening (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations), or those who have participated in radiolabeled drug trials within 1 year prior to screening;
- History of drug abuse or substance abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine);
- Average weekly alcohol consumption of ≥14 units within 3 months prior to screening (1 unit ≈ 360 mL beer, or 45 mL liquor, or 150 mL wine), or positive breath alcohol test;
- Average daily smoking of >5 cigarettes (or equivalent nicotine products) within 3 months prior to dosing, or inability to discontinue any tobacco products during the study, or positive cotinine test;
- Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL), and inability to abstain during the study; or consumption of any chocolate, caffeine, or xanthine-rich foods or beverages within 48 hours prior to dosing;
- Vaccination within 4 weeks prior to dosing, or planned vaccination within 1 month after dosing;
- Other reasons deemed by the investigator as making the participant unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants
According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a [¹⁴C] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.
- Being tested
- [¹⁴C]Hydronidone
- Keywords
- Chronic Hepatitis B-related liver fibrosis, Hydronidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]HydronidoneDrug
Enrolled participants fasted for at least 10 hours prior to dosing. On the morning of Day 1 (D1), a single oral dose of [¹⁴C]Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C]Hydronidone) was administered under fasting conditions, with approximately 240 mL of water used for preparation and administration. Except for the water used for dosing, no water was permitted within 1 hour before and after administration. Participants remained in the isotope ward of the study center from dosing until Day 9 (D9), which could be shortened or extended depending on whether the sample collection termination criteria were met."
| Study group | Role | What they receive |
|---|---|---|
| [¹⁴C] Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C] Hydronidone) | Experimental | On the morning of Day 1 (D1), a single oral dose was administered under fasting conditions. Receives: Drug: [¹⁴C]Hydronidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative radioactive recovery in excreta (urine and feces) per collection period
Measured: within 9 days after dosing
Cumulative total radioactive recovery in excreta (urine and feces)
Measured: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Cmax
Measured: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Tmax
Measured: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : t1/2
Measured: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : MRT
Measured: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : AUC
Measured: within 9 days after dosing
Whole blood ratio of total radioactivity concentration
Measured: within 9 days after dosing
plasma ratio of total radioactivity concentration
Measured: within 9 days after dosing
Percentage of unchanged drug relative to total radioactivity exposure in plasma
Measured: within 9 days after dosing
Percentage of unchanged drug in urine relative to the administered dose (%Dose)
Measured: within 9 days after dosing
Percentage of unchanged drug in feces relative to the administered dose (%Dose)
Measured: within 9 days after dosing
Identification of major metabolites in plasma
Measured: within 9 days after dosing
Identification of major metabolites in urine
Measured: within 9 days after dosing
Identification of major metabolites in feces
Measured: within 9 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start17 Apr 2026
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B-related 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT07471217
- Sponsor's protocol ID
- KDN-F351-202506
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2026
- 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
- [¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT07471217
- Acronym / sponsor ID
- KDN-F351-202506
- Keywords
- Chronic Hepatitis B-related liver fibrosis, Hydronidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 13 Mar 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.
According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a [¹⁴C] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [¹⁴C] Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C] Hydronidone) | Experimental | Drug: [¹⁴C]HydronidoneOn the morning of Day 1 (D1), a single oral dose was administered under fasting conditions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form;
- Chinese adult male participants aged 18 to 50 years (inclusive);
- Participants weighing at least 50 kg at screening, with a body mass index [BMI = weight (kg) / height² (m²)] within the range of 19.0 to 26.0 kg/m² (inclusive);
- Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner.
Key exclusion criteria (20 listed)
- The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system;
- Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant;
- Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant;
- Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody;
- Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except for appendectomy), or plans to undergo surgery during the trial period;
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 |
|---|---|---|
| [¹⁴C]HydronidoneEnrolled participants fasted for at least 10 hours prior to dosing. On the morning of Day 1 (D1), a single oral dose of [¹⁴C]Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C]Hydronidone) was administered under fasting conditions, with approximately 240 mL of water used for preparation and administration. Except for the water used for dosing, no water was permitted within 1 hour before and after administration. Participants remained in the isotope ward of the study center from dosing until Day 9 (D9), which could be shortened or extended depending on whether the sample collection termination criteria were met." | Drug | [¹⁴C] Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C] Hydronidone) |
Primary outcome
Cumulative radioactive recovery in excreta (urine and feces) per collection period
Time frame: within 9 days after dosing
Cumulative total radioactive recovery in excreta (urine and feces)
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Cmax
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Tmax
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : t1/2
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : MRT
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : AUC
Time frame: within 9 days after dosing
Whole blood ratio of total radioactivity concentration
Time frame: within 9 days after dosing
plasma ratio of total radioactivity concentration
Time frame: within 9 days after dosing
Percentage of unchanged drug relative to total radioactivity exposure in plasma
Time frame: within 9 days after dosing
Percentage of unchanged drug in urine relative to the administered dose (%Dose)
Time frame: within 9 days after dosing
Percentage of unchanged drug in feces relative to the administered dose (%Dose)
Time frame: within 9 days after dosing
Identification of major metabolites in plasma
Time frame: within 9 days after dosing
Identification of major metabolites in urine
Time frame: within 9 days after dosing
Identification of major metabolites in feces
Time frame: within 9 days after dosing
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.
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 [¹⁴C]Hydronidone in people with Chronic Hepatitis B-related 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 4 inclusion and 20 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. 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?
Cumulative radioactive recovery in excreta (urine and feces) per collection period (time frame: within 9 days after dosing). The study lists 15 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 26 Oct 2026.