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New drug HRS-8427 tested for liver enzyme interactions in healthy volunteers

NCT ID NCT07049107

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This completed Phase 1 study looked at how an experimental drug called HRS-8427 affects the liver's ability to process other medications. Fourteen healthy adults took HRS-8427 along with two common drugs (bupropion and midazolam) to see if it changed their levels in the blood. The goal was to understand potential drug interactions, not to treat any disease.

What this could mean

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

Active substance
HRS-8427
What this could lead to
If successful, this study could help doctors understand how HRS-8427 interacts with other medications, guiding safer use in future patients.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. Results may not predict real-world effects or safety in sick people.

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

14 people

The number who actually took part.

Started

Jun 2025

Finished

Jul 2025

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 45 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: 1. Healthy subjects aged 18 to 45 years old (including 18 and 45 years old, based on the time of signing the informed consent form), both male and female. 2. The weight of female subjects was ≥45 kg, the weight of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-26.0 kg/m2 3. The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator. 4. Before the trial, a thorough understanding of the nature, significance, potential benefits, possible inconveniences and potential risks of the trial was obtained. The participant voluntarily participated in this clinical trial, was able to communicate well with the researcher, comply with the requirements of the entire study, and signed a written informed consent form. Exclusion Criteria: 1. Those with a history of allergies to food, drugs, etc., especially those known to be allergic to β -lactam antibacterial drugs and midazolam, bupropion, or those with an allergic constitution. 2. Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc. 3. Conforming to the contraindications of midazolam use or not suitable for midazolam use . 4. Comply with the contraindications for bupropion use or are not suitable for bupropion use . 5. The 12-lead electrocardiogram was abnormal and was judged by the researcher as unsuitable to participate in this study . 6. Laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), physical examination, vital signs (ears, blood pressure, pulse, respiration), and chest X-ray results, etc., which are judged by clinicians as abnormal and of clinical significance . 7. Those with positive infectious disease tests (human immunodeficiency virus antibody, hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum specific antibody). 8. Those who have undergone major surgical operations within the three months prior to screening; Or those who have undergone surgery that may affect the in vivo process or safety evaluation of the studied drug; Or those who plan to undergo surgical operations during the research period. 9. Those who have participated in drug clinical trials as subjects and taken the investigational drug within 3 months prior to screening, or who plan to participate in other clinical trials during this study period . 10. Those who have used any inducers or inhibitors of CYP2B6 and CYP3A enzymes within one month before taking the study drug for the first time.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

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