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Liver function and drug processing: a safety study

NCT ID NCT07625618

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at how a single dose of MY008211A tablets moves through the body in people with different levels of liver function. 24 adults (some with liver problems, some without) took part. The goal was to understand safety and how the liver affects drug levels, not to treat any condition.

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

24 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2024

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 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements; * Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female; * Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive); * Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs; * Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min; Exclusion Criteria: * Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency; * Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila. * Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection; * Active systemic bacterial, viral or fungal infections within 14 days before administration; * Fever (≥ 38°C) within 7 days before administration; * Subjects suspected of having a history of allergy to any component of the investigational product, or with allergic constitution (allergic to multiple drugs and foods, and judged by the investigator to be clinically significant); * Those who have previously undergone surgery that, as judged by the investigator, will affect drug absorption, distribution, metabolism and excretion; or those who have undergone surgery within 4 weeks prior to screening; or those who plan to undergo surgery during the study; * Those who cannot tolerate venipuncture or with a history of blood phobia and acupuncture syncope;

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Conditions

The condition(s) this trial relates to.

Hepatic Insufficiency liver disorder liver failure

As listed by the trial registrant

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

Contacts and locations

Locations

  • The First Hospital of Jilin University

    Jilin City, Changchun, 130000, China

More trials for these conditions

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