Hepatic FibrosisPhase 1NCT07263152
QTc Assessment in a Single-Dose Study of Hydronidone Capsules
A Phase 1 study testing Hydronidone in people with Hepatic Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
This study was designed with three dose cohorts (A1-A3): a 90 mg cohort, a 270 mg cohort, and a 540 mg cohort. Each cohort enrolled 16 healthy Chinese participants, with 12 receiving the investigational product Hydronidone Capsules and 4 receiving placebo (i.e., matching placebo for Hydronidone Capsules). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Fibrosis
- What is being tested?
- Hydronidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 9 Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Participants who were fully informed about this trial before the experiment, understood the content, process and possible adverse events related to the experimental drug, and voluntarily signed the written informed consent form.
- 2) Male or female participants aged 18 to 50 years (including the upper and lower limits) at the time of signing the informed consent form.
- 3) Male participants with a weight of ≥50.0 kg and female participants with a weight of ≥45.0 kg at the time of screening, and a body mass index (BMI) of 19.0 to 26.0 kg/m2, including the boundary values.
- 4) Participants whose medical history inquiries, laboratory tests and related examinations (vital signs, physical examination, 12-lead ECG, chest X-ray, abdominal color Doppler ultrasound, etc.) were all normal or whose abnormalities were judged by the researcher to have no clinical significance at the time of screening.
Who cannot join
- 1) The researcher determines that there are other diseases or medical histories that have clinical significance or may prevent participants from following the research protocol and completing 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, nervous system, endocrine and metabolic system, etc.
- 2) There is a history of cardiovascular system diseases or risk factors for torsade de pointes (TdP) such as: unexplained syncope; heart failure; myocardial infarction; angina pectoris; atrial fibrillation, atrial flutter, premature ventricular contractions, non-continuous or continuous ventricular tachycardia; severe bradycardia or sick sinus syndrome; hypokalemia or hypomagnesemia; history of interstitial lung disease, pulmonary embolism; history of venous thromboembolism; any personal or family history of cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden death.
- 3) During the screening period or baseline period, the 12-lead electrocardiogram exceeds the standard: PR > 220ms, QRS > 110ms, HR < 50 bpm, QTcF ≥ 450 ms; or an abnormal electrocardiogram and the researcher considers it abnormal and of clinical significance (such as, second-degree or higher atrioventricular block, potential bundle branch block, torsade de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, any clinically significant T wave changes or any 12-lead electrocardiogram (ECG) results abnormal that affects the QTc interval).
- 4）Those whose test results for any of the following infectious disease indicators are positive during the screening period: hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen and antibody, or syphilis spirochete antibody;
- 5) Those with a history of drug or food allergies, or specific allergies (such as asthma, urticaria, eczema, etc.); or those allergic to hydroxynitone capsules or to the excipient ingredients contained therein;
- 6) Those who have suffered from a major clinically significant disease within 3 months before the screening or have undergone surgeries that affect drug absorption, distribution, metabolism, excretion (such as gastrointestinal digestive tract, liver and kidney-related surgeries) or other major surgeries, or those who plan to undergo surgery during the study period;
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- 7) Those who have donated blood or lost blood ≥ 400 mL within 3 months before administration, or have received blood transfusion or used blood products within 4 weeks before administration, or those who plan to donate blood during this study period;
- 8) Those who have participated in any clinical trials as participants and received treatment with trial drugs or devices within 3 months before administration;
- 9) Those who have taken any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before administration, or within 5 half-lives (whichever is longer) before administration (based on the longer time period); those who have taken CYP3A4 strong inhibitors or strong inducers within 4 weeks before administration, or any drugs known to cause QT/QTc interval prolongation or have a risk of causing torsades de pointes (TdP) (refer to Appendix 10.2); or those who plan to use some chemical drugs, biological products, traditional Chinese medicine or natural medicines that the investigators consider not suitable for taking during the study period;
- 10) Those who received vaccinations within the past 4 weeks, or those who plan to receive vaccinations during the study period up to 1 month after administration;
- 11) Those with a history of drug abuse in the past 5 years or within 3 months before screening, or those with positive urine drug abuse screening results at baseline;
- 12) Those who frequently drink alcohol within 6 months before administration, that is, consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or those who refuse to stop drinking or consuming any alcoholic products during the trial, or those with positive alcohol breath test results at baseline;
- 13) Those who smoke more than 5 cigarettes per day 3 months before administration, or those who cannot stop using tobacco products during the trial;
- 14) Those with a history of motion sickness or needle phobia, or those who cannot tolerate venous catheter puncture;
- 15) Those with special dietary requirements, those who cannot follow a uniform diet or those who have difficulty swallowing;
- 16) Those who cannot control their special diet during the trial (including dragon fruit, mango, grapefruit or grapefruit-related citrus fruits (such as lime, pomelo), rambutan, papaya, pomegranate or their products, and/or xanthine diet, caffeinated food or beverages, strong tea, etc.);
- 17) Those who have taken grapefruit-related citrus fruits (such as lime, pomelo) or their products within 2 weeks before administration, or those who have taken special diets (including dragon fruit, mango or xanthine diet, caffeinated food or beverages, strong tea, etc.) within 48 hours before administration, or those who have engaged in intense exercise, or have other factors affecting drug absorption, distribution, metabolism, and excretion;
- 18) Pregnant or lactating women, or participants with positive blood pregnancy screening results during the trial;
- 19) Participants with reproductive capacity who do not agree to use effective contraceptive methods from the time of signing the informed consent form until the end of the trial (see Appendix 3); or those who do not agree to avoid cryopreservation or donation of eggs or sperm during this period;
- 20) Those who, in the judgment of the investigator, have other reasons that make them unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effect of Single-Dose Hydronidone Capsules on QTc Interval in Chinese Healthy Subjects
This study was designed with three dose cohorts (A1-A3): a 90 mg cohort, a 270 mg cohort, and a 540 mg cohort. Each cohort enrolled 16 healthy Chinese participants, with 12 receiving the investigational product Hydronidone Capsules and 4 receiving placebo (i.e., matching placebo for Hydronidone Capsules). A total of 48 healthy Chinese subjects were planned for enrollment, and all participants received a single dose under fasting conditions.
- Conditions
- Hepatic Fibrosis
- Being tested
- Hydronidone, Placebo
- Keywords
- Hydronidone, QTc
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydronidoneDrug
Experimental group
PlaceboDrug
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Experimental | Single-dose administration of 90 mg Receives: Drug: Hydronidone |
| Placebo Group A1 | Placebo comparator | Single-dose administration of 90 mg Receives: Drug: Placebo |
| Group A2 | Experimental | Single-dose administration of 270 mg Receives: Drug: Hydronidone |
| Placebo Group A2 | Placebo comparator | Single-dose administration of 270 mg Receives: Drug: Placebo |
| Group A3 | Experimental | Single-dose administration of 540 mg Receives: Drug: Hydronidone |
| Placebo Group A3 | Placebo comparator | Single-dose administration of 540 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between plasma drug concentration and placebo-corrected change from baseline in QTc interval (ΔΔQTc) following single-dose administration of Hydroxynidone Capsules
Measured: 24 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 posted4 Dec 2025
- Study start30 Dec 2025
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- 48 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
- NCT07263152
- Sponsor's protocol ID
- KDN-F351-202504
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2025
- 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, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effect of Single-Dose Hydronidone Capsules on QTc Interval in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT07263152
- Acronym / sponsor ID
- KDN-F351-202504
- Conditions
- Hepatic Fibrosis
- Keywords
- Hydronidone, QTc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 4 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.
This study was designed with three dose cohorts (A1-A3): a 90 mg cohort, a 270 mg cohort, and a 540 mg cohort. Each cohort enrolled 16 healthy Chinese participants, with 12 receiving the investigational product Hydronidone Capsules and 4 receiving placebo (i.e., matching placebo for Hydronidone Capsules). A total of 48 healthy Chinese subjects were planned for enrollment, and all participants received a single dose under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Experimental | Drug: HydronidoneSingle-dose administration of 90 mg |
| Placebo Group A1 | Placebo comparator | Drug: PlaceboSingle-dose administration of 90 mg |
| Group A2 | Experimental | Drug: HydronidoneSingle-dose administration of 270 mg |
| Placebo Group A2 | Placebo comparator | Drug: PlaceboSingle-dose administration of 270 mg |
| Group A3 | Experimental | Drug: HydronidoneSingle-dose administration of 540 mg |
| Placebo Group A3 | Placebo comparator | Drug: PlaceboSingle-dose administration of 540 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1) Participants who were fully informed about this trial before the experiment, understood the content, process and possible adverse events related to the experimental drug, and voluntarily signed the written informed consent form.
- 2) Male or female participants aged 18 to 50 years (including the upper and lower limits) at the time of signing the informed consent form.
- 3) Male participants with a weight of ≥50.0 kg and female participants with a weight of ≥45.0 kg at the time of screening, and a body mass index (BMI) of 19.0 to 26.0 kg/m2, including the boundary values.
- 4) Participants whose medical history inquiries, laboratory tests and related examinations (vital signs, physical examination, 12-lead ECG, chest X-ray, abdominal color Doppler ultrasound, etc.) were all normal or whose abnormalities were judged by the researcher to have no clinical significance at the time of screening.
Key exclusion criteria (20 listed)
- 1) The researcher determines that there are other diseases or medical histories that have clinical significance or may prevent participants from following the research protocol and completing 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, nervous system, endocrine and metabolic system, etc.
- 2) There is a history of cardiovascular system diseases or risk factors for torsade de pointes (TdP) such as: unexplained syncope; heart failure; myocardial infarction; angina pectoris; atrial fibrillation, atrial flutter, premature ventricular contractions, non-continuous or continuous ventricular tachycardia; severe bradycardia or sick sinus syndrome; hypokalemia or hypomagnesemia; history of interstitial lung disease, pulmonary embolism; history of venous thromboembolism; any personal or family history of cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden death.
- 3) During the screening period or baseline period, the 12-lead electrocardiogram exceeds the standard: PR > 220ms, QRS > 110ms, HR < 50 bpm, QTcF ≥ 450 ms; or an abnormal electrocardiogram and the researcher considers it abnormal and of clinical significance (such as, second-degree or higher atrioventricular block, potential bundle branch block, torsade de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, any clinically significant T wave changes or any 12-lead electrocardiogram (ECG) results abnormal that affects the QTc interval).
- 4）Those whose test results for any of the following infectious disease indicators are positive during the screening period: hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen and antibody, or syphilis spirochete antibody;
- 5) Those with a history of drug or food allergies, or specific allergies (such as asthma, urticaria, eczema, etc.); or those allergic to hydroxynitone capsules or to the excipient ingredients contained therein;
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 |
|---|---|---|
| HydronidoneExperimental group | Drug | Group A1, Group A2, Group A3 |
| PlaceboPlacebo group | Drug | Placebo Group A1, Placebo Group A2, Placebo Group A3 |
Primary outcome
The relationship between plasma drug concentration and placebo-corrected change from baseline in QTc interval (ΔΔQTc) following single-dose administration of Hydroxynidone Capsules
Time frame: 24 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 in people with Hepatic 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 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. 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?
The relationship between plasma drug concentration and placebo-corrected change from baseline in QTc interval (ΔΔQTc) following single-dose administration of Hydroxynidone Capsules (time frame: 24 hours after administration). 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.