Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New liver Drug's safety check: can it mix with hepatitis b antivirals?

NCT ID NCT07295873

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This early-stage trial will test a new drug called hydronidone, which is being developed for liver fibrosis caused by hepatitis B. Since patients often need to take antiviral drugs for hepatitis B, researchers want to see if hydronidone can be taken safely alongside four common antivirals. The study involves 64 healthy Chinese adults and will measure how the drugs interact in the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydronidone
What this could lead to
If successful, this study will show that hydronidone can be safely taken alongside common hepatitis B antivirals, paving the way for a combination treatment for liver fibrosis.
What could go wrong
This is an early Phase 1 trial in only 64 healthy people, not patients. It only checks drug interactions, not whether hydronidone actually treats liver fibrosis. Side effects may still emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

64 people

The number who actually took part.

Started

Mar 2026

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be fully informed about the trial and demonstrate understanding of its content, procedures, and potential adverse events related to the investigational product; voluntarily provide written informed consent; and be able to comply with all study procedures and complete the study in accordance with the protocol requirements. * Male or female subjects aged 18 to 50 years, inclusive, at the time of signing informed consent. * At screening, male subjects must weigh ≥50.0 kg and female subjects must weigh ≥45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive. * At screening, all laboratory tests and related examinations (including vital signs, physical examination, 12-lead ECG, chest X-ray \[PA view\], abdominal ultrasound, etc.) must be within normal range or, if abnormal, determined by the investigator to be not clinically significant. Exclusion Criteria: * Presence of any clinically significant disease or medical history that, in the opinion of the investigator, may interfere with protocol compliance or completion of the study, including but not limited to abnormalities of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, immune system, psychiatric system, or endocrine/metabolic system. * Positive results for any infectious disease screening tests at screening, including hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antigen/antibody (HIV Ag/Ab), or Treponema pallidum antibody (TP Ab). * History of drug or food allergies, or known hypersensitivity to the active pharmaceutical ingredients of the investigational medicinal products (hydronidone, entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide) or to any of their excipients. * Participants with rare genetic disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption; * Subjects who have experienced a clinically significant major illness within 3 months prior to screening, or have undergone surgery affecting drug absorption, distribution, metabolism, or excretion (such as gastrointestinal, hepatic, or renal surgery) or other major surgery within this period, or plan to undergo surgery during the study; * Subjects who have donated blood or experienced blood loss ≥400 mL within 3 months prior to dosing, or received blood transfusion or blood products within 4 weeks prior to dosing, or plan to donate blood during the study period; * Subjects who have participated as a participant in any clinical trial and received investigational drug or device treatment within 3 months prior to dosing; * Subjects who have taken any prescription medication, over-the-counter medication, vitamin products, or herbal medicines within 14 days or 5 half-lives (if known) prior to dosing, whichever is longer; or who have taken strong inhibitors or inducers of CYP3A4, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1/3 within 4 weeks prior to screening; or any drugs known to cause QT/QTc interval prolongation or with a known risk of causing torsades de pointes (TdP) (see Appendix 2); or plan to use any chemical drugs, biological products, traditional Chinese medicines, or natural medicines that the investigator deems inappropriate during the trial period; * Subjects who received vaccination within 4 weeks prior to screening, or plan to receive vaccination during the study period up to 1 month after the last dose; Subjects with a history of drug abuse within the past 5 years, or who used illicit drugs within 3 months prior to screening, or with a positive urine drug abuse screen at baseline; * Subjects who regularly consumed alcohol within 6 months prior to dosing, i.e., 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 who refuse to abstain from alcohol or alcohol-containing products during the trial, or with a positive alcohol breath test at baseline; * Subjects who smoked more than 5 cigarettes daily within 3 months prior to dosing, or who are unable to discontinue use of tobacco products during the trial period; * Subjects with a history of blood-needle phobia/syncope, or unable to tolerate venous indwelling needle puncture; * Subjects with special dietary requirements who cannot follow the standardized diet, or with difficulty swallowing; * Subjects unable to avoid specific foods/diet during the trial period, including dragon fruit, mango, grapefruit or grapefruit-related citrus fruits (e.g., Seville orange, pomelo), star fruit, papaya, pomegranate or products thereof, and/or xanthine-containing diet, caffeine-containing food or beverages, strong tea, etc.; * Subjects who consumed grapefruit or grapefruit-related citrus fruits (e.g., Seville orange, pomelo) or products thereof within 2 weeks prior to dosing, or who consumed specific diet (including dragon fruit, mango and/or xanthine-containing diet, caffeine-containing food or beverages, strong tea, etc.) within 48 hours prior to dosing, or engaged in strenuous exercise, or have other factors that may affect drug absorption, distribution, metabolism, or excretion; * Pregnant or lactating women, or female subjects of childbearing potential with a positive serum pregnancy test at screening; * Subjects of childbearing potential who do not agree to use effective contraceptive methods from the time of signing informed consent until 3 months after study completion (see Appendix 3), or do not agree to avoid freezing or donating eggs or sperm during this period; * Subjects who, in the opinion of the investigator, have other reasons that render them unsuitable for participation in this study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic hepatitis B liver fibrosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Gaobo Hospital

    Beijing, 100000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.