Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

How HS-10506 behaves in people with moderate liver problems compared to healthy individuals

Official title: A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506

Run by Jiangsu Hansoh Pharmaceutical Co., Ltd. · NCT07844967 · Data updated 2026-11-12

This study tests a single 20 mg dose of HS-10506 to see how people with moderate hepatic impairment process the drug compared with people with normal liver function.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment32 (estimated)
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
Industry-sponsored
Locations1 site (Hefei, Anhui)
StatusRecruiting
StartedJune 1, 2026
Main results expectedJune 1, 2028
Study endsJune 1, 2028
Registry record updatedSeptember 28, 2026
Trial IDNCT07844967 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years and older with either stable mild/moderate hepatic impairment or matched normal hepatic function and BMI/age/gender alignment as specified.

Probably not a fit

Patients with unstable hepatic status or other major health issues not meeting inclusion criteria may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, multicenter, open-label, parallel-group study assessing the pharmacokinetics of HS-10506 after a single oral dose. Two cohorts are enrolled: one with moderate hepatic impairment and one with normal hepatic function, each planned to include eight adults. Participants are admitted the day before dosing, fast for at least 10 hours, receive 20 mg HS-10506 in the fasted state, and are restricted from food for four hours post-dose. The study uses matched controls to compare hepatic impairment effects on drug exposure, with strict dosing and hydration protocols. Depending on moderate impairment results, a potential mild impairment study phase may be considered.

Why it matters

Potential benefit: If successful, results could guide dosing recommendations for patients with varying levels of liver function.

How similar studies have gone: Phase 1 PK studies in hepatic impairment have been conducted for similar compounds, supporting the feasibility of this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements.

* 18 years of age, male or female. BMI 19.0\~32.0 kg/m² and body weight \>50 kg of male and \>45 kg of female.

Cohort A \& C (with hepatic impairment):

Stable hepatic impairment classified as Child-Pugh Class A (mild) and B (moderate) No clinically significant worsening of hepatic status at least 2 months.

Cohort B \& D (without hepatic impairment):

BMI matched with hepatic impairment, mean ±10% Age matched with hepatic impairment, mean ±3 years Gender matched with hepatic impairment

Exclusion Criteria:

Alpha-fetoprotein (AFP) \> 20 ng/mL at screening. Current or past history of mental disorders or cerebral dysfunction; participants with suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); history of self-harm or suicide attempt within 1 year prior to screening; or participants deemed to be at suicide risk based on the investigator's clinical judgment.

Past or current severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., abnormal airway anatomical structures, congenital macroglossia, mandibular dysplasia; chronic obstructive pulmonary disease, obstructive sleep apnea syndrome), urinary system or other systemic diseases, which are considered unsuitable for study participation by the investigator.

Past or current active gastrointestinal diseases and symptoms including active gastric ulcer and reflux esophagitis (e.g., heartburn, acid regurgitation), which are deemed unsuitable for enrollment by the investigator.

A history of surgeries that may affect drug absorption, distribution, metabolism and excretion (ADME), and considered unsuitable for enrollment by the investigator.

Susceptibility to allergic reactions, allergic diathesis (e.g., allergy to pollen, two or more drugs or food items), or known hypersensitivity to any ingredients of the investigational product.

Participation in any other clinical trial and administration of any investigational medicinal products or devices within 3 months prior to screening; or within 7 elimination half-lives of other study drugs at screening, whichever is longer.

Use of strong or moderate CYP3A inhibitors or inducers within 30 days prior to the first dose of investigational product (or 7 times the corresponding elimination half-life, whichever is longer).

Use of any medications that alter gastric pH within 14 days prior to the first dose of investigational product .

History of massive blood loss (\> 400 mL) or blood donation within 3 months prior to screening; or planned blood donation during the study period and within 3 months after study completion.

Significant changes in dietary or sleeping habits within 4 weeks prior to screening, which are considered unsuitable for study participation by the investigator.

Consumption of grapefruit or grapefruit-containing products within 48 hours prior to the first dose of investigational product.

Excessive intake of tea, coffee or caffeinated beverages within 3 months prior to screening (average daily intake \> 8 cups; 1 cup = 200 mL).

Average daily cigarette consumption of more than 5 cigarettes within 3 months prior to screening, or inability to abstain from all tobacco products during the study.

Regular alcohol consumption within 3 months prior to screening (i.e., more than 14 alcohol units per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer, 45 mL 40% alcohol spirit, or 150 mL wine) or inability to abstain from alcoholic beverages during the study.

Intake of any alcohol-containing products within 24 hours prior to investigational product administration, or a positive breath alcohol test result.

History of substance abuse or dependence, or illicit drug use within 5 years prior to screening, or positive urine drug screen result.

Administration of albumin within 14 days prior to the first dose of investigational product.

Lactating or pregnant women; or positive serum pregnancy test with clinically significant abnormalities as judged by the investigator.

Inability to tolerate venous puncture or indwelling needle blood collection, or fear of needles or blood.

Any other conditions that may prevent the subject from completing the study, or other factors deemed unsuitable for study participation by the investigator.

Participants with normal hepatic function will be excluded if they meet any of the following criteria:

Clinically significant abnormalities identified by the investigator in physical examination, vital signs, electrocardiogram (ECG), abdominal ultrasound, chest X-ray, or clinical laboratory tests.

Positive result for any of the following at screening: hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum antibody, human immunodeficiency virus (HIV) antigen/antibody.

Prolonged QT interval on 12-lead ECG at screening (QTcF \> 450 ms for males, QTcF \> 470 ms for females).

Use of any prescription drugs, over-the-counter drugs, traditional Chinese herbal medicines or dietary supplements within 14 days prior to the first dose of investigational product (excluding topically administered agents with local effects); or within 7 elimination half-lives of any prior medication, whichever is longer.

History of hepatic injury.

Participants with hepatic impairment will be excluded if they meet any of the following criteria:

Positive HIV antigen/antibody or positive anti-Treponema pallidum antibody. Positive hepatitis B surface antigen with hepatitis B viral DNA above the upper limit of detection; or positive anti-hepatitis C virus antibody with hepatitis C viral RNA above the upper limit of detection.

Further exclusion criteria apply.

Where it's running

  • No. 121, Wanshui Road, Hefei High-tech Zone
    Hefei, Anhui, China
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.