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RecruitingNCT07844967HS-10506-114Updated Sep 28, 2026

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

A Phase 1 interventional study of HS-10506 in Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Moderate Hepatic Impairment Study Phase

This phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase:

Cohort A: Subjects with moderate hepatic impairment Cohort B: Subjects with normal hepatic function A total of 8 subjects of either gender will be enrolled in each cohort. Enrolled subjects will be admitted to the Phase I clinical research unit on Day -1 and fasted for at least 10 hours. On Day 1, subjects will receive a single oral dose of 20 mg HS-10506 tablets in a fasted state. Water intake is prohibited within 1 hour before and after dosing (excluding water used for drug administration). Food intake is restricted for at least 4 hours post-dose. All study medications will be administered with approximately 240 mL of water.

Subjects with normal hepatic function (Cohort B) serve as the matched control group for subjects with moderate hepatic impairment (Cohort A), and shall meet the following matching criteria:

The mean body mass index (BMI) of Cohort B is within ±10% of the mean BMI of Cohort A.

The mean age of Cohort B is within ±3 years of the mean age of Cohort A. The number of male and female subjects in Cohort B is consistent with that in Cohort A for each gender.

Mild Hepatic Impairment Study Phase Based on the results of the moderate hepatic impairment study phase, the sponsor and principal investigator will jointly determine whether to conduct a study to evaluate the effect of mild hepatic impairment. The phase design and procedures of the mild hepatic impairment are consistent with those of the moderate hepatic impairment.

Subjects with normal hepatic function (Cohort D) serve as the matched control group for subjects with mild hepatic impairment (Cohort C), and shall meet the following matching criteria:

The mean BMI of Cohort D is within ±10% of the mean BMI of Cohort C. The mean age of Cohort D is within ±3 years of the mean age of Cohort C. The number of male and female subjects in Cohort D is consistent with that in Cohort C for each gender.

Read the detailed description

Moderate Hepatic Impairment Study Phase

This phase employs a multicenter, open-label, parallel-group, single-dose study design. Two cohorts are established in this phase:

Cohort A: Subjects with moderate hepatic impairment Cohort B: Subjects with normal hepatic function A total of 8 subjects of either gender will be enrolled in each cohort. Enrolled subjects will be admitted to the Phase I clinical research unit on Day -1 and fasted for at least 10 hours. On Day 1, subjects will receive a single oral dose of 20 mg HS-10506 tablets in a fasted state. Water intake is prohibited within 1 hour before and after dosing (excluding water used for drug administration). Food intake is restricted for at least 4 hours post-dose. All study medications will be administered with approximately 240 mL of water.

Subjects with normal hepatic function (Cohort B) serve as the matched control group for subjects with moderate hepatic impairment (Cohort A), and shall meet the following matching criteria:

The mean body mass index (BMI) of Cohort B is within ±10% of the mean BMI of Cohort A.

The mean age of Cohort B is within ±3 years of the mean age of Cohort A. The number of male and female subjects in Cohort B is consistent with that in Cohort A for each gender.

Mild Hepatic Impairment Study Phase Based on the results of the moderate hepatic impairment study phase, the sponsor and principal investigator will jointly determine whether to conduct a study to evaluate the effect of mild hepatic impairment. The phase design and procedures of the mild hepatic impairment are consistent with those of the moderate hepatic impairment.

Subjects with normal hepatic function (Cohort D) serve as the matched control group for subjects with mild hepatic impairment (Cohort C), and shall meet the following matching criteria:

The mean BMI of Cohort D is within ±10% of the mean BMI of Cohort C. The mean age of Cohort D is within ±3 years of the mean age of Cohort C. The number of male and female subjects in Cohort D is consistent with that in Cohort C for each gender.

02

Conditions studied

  • Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function

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Keywords

  • HS-10506
  • Hepatic Impairment
  • Pharmacokinetics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Cohort A: Subjects with moderate hepatic impairment

    Drug: HS-10506

  • Active comparator
    Cohort B: Subjects with normal hepatic function

    Drug: HS-10506

  • Experimental
    Cohort C: Subjects with mild hepatic impairment

    Drug: HS-10506

  • Active comparator
    Cohort D: Subjects with normal hepatic function

    Drug: HS-10506

Interventions

  • DrugHS-10506

    Administered orally

05

What researchers measure

Primary outcomes

  1. PK parameter of HS-10506: Cmax

    Maximum observed plasma concentration

    Time frame: Day 1 pre-dose to 120 hours post-dose

  2. PK parameter of HS-10506: AUC0-t

    Area under the plasma concentration-time curve from time 0 to the last quantifiable time point

    Time frame: Day 1 pre-dose to 120 hours post-dose

  3. PK parameter of HS-10506: AUC0-∞

    Area under the plasma concentration-time curve from time 0 to infinity

    Time frame: Day 1 pre-dose to 120 hours post-dose

Secondary outcomes

  1. PK parameter of HS-10506: CL/F

    Apparent total clearance of HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose

  2. PK parameter of HS-10506: Tmax

    Time to reach maximum observed plasma concentration of HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose

  3. PK parameter of HS-10506: t1/2z

    Terminal elimination half-life of HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose

  4. PK parameter of HS-10506:fu

    Unbound fraction of HS-10506 in plasma (%)

    Time frame: Day 1 pre-dose to 120 hours post-dose

  5. PK parameter of HS-10506:Cmax,Unboundd

    Maximum observed unbound plasma concentration of HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose

  6. PK parameter of HS-10506:AUC0-t,Unbound

    Area under the unbound plasma concentration-time curve from time 0 to the last quantifiable time point of HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose

  7. PK parameter of HS-10506:AUC0-∞,Unbound

    Area under the unbound plasma concentration-time curve from time 0 to infinity of HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose

  8. Adverse events

    Incidence of adverse events

    Time frame: Screening Day, Day 1 to Day 6

  9. vital signs

    Number of participants with abnormal vital signs

    Time frame: Screening Day, Day 1 to Day 6

  10. Laboratory tests

    Number of participants with abnormal laboratory test values

    Time frame: Screening Day, Day 1 to Day 6

  11. 12-lead ECG

    Number of participants with abnormal 12-lead ECG findings

    Time frame: Screening Day, Day 1 to Day 6

  12. Physical examination

    Number of participants with abnormal physical examination findings

    Time frame: Screening Day, Day 1 to Day 6

  13. PK parameter of HS-10506: Vz/F

    Apparent volume of distribution during the terminal phase of HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose]

  14. PK parameter of HS-10506: CL/FUnbound

    Apparent total clearance of unbound HS-10506

    Time frame: Day 1 pre-dose to 120 hours post-dose

06

Study locations

1 of 1 sites recruiting
  • No. 121, Wanshui Road, Hefei High-tech Zone
    Hefei, Anhui 230088, China
    Recruiting
07

Registry details

Key details

Study ID
NCT07844967
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Jun 1, 2026
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Huan Zhou, Doctorate
Contact
zhouhuanbest@vip.163.com
0086-13665527160

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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