Hepatic Impairment (Moderate or Mild) & Normal Hepatic FunctionPhase 1HS-10506-114NCT07844967
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506
A Phase 1 study testing HS-10506 in people with Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function
- What is being tested?
- HS-10506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No. 121, Wanshui Road, Hefei High-tech Zone
Hefei, Anhui, 230088
Huan Zhou, Doctorate, 0086-13665527160, zhouhuanbest@vip.163.com
About this study
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:
Read more
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.
- Being tested
- HS-10506
- Keywords
- HS-10506, Hepatic Impairment, Pharmacokinetics
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10506Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Subjects with moderate hepatic impairment | Experimental | Not described Receives: Drug: HS-10506 |
| Cohort B: Subjects with normal hepatic function | Active comparator | Not described Receives: Drug: HS-10506 |
| Cohort C: Subjects with mild hepatic impairment | Experimental | Not described Receives: Drug: HS-10506 |
| Cohort D: Subjects with normal hepatic function | Active comparator | Not described Receives: Drug: HS-10506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter of HS-10506: Cmax
Maximum observed plasma concentration
Measured: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506: AUC0-t
Area under the plasma concentration-time curve from time 0 to the last quantifiable time point
Measured: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506: AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity
Measured: Day 1 pre-dose to 120 hours post-dose
Secondary outcomes (14)
PK parameter of HS-10506: CL/F
Apparent total clearance of HS-10506
Measured: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506: Tmax
Time to reach maximum observed plasma concentration of HS-10506
Measured: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506: t1/2z
Terminal elimination half-life of HS-10506
Measured: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506:fu
Unbound fraction of HS-10506 in plasma (%)
Measured: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506:Cmax,Unboundd
Maximum observed unbound plasma concentration of HS-10506
Measured: Day 1 pre-dose to 120 hours post-dose
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
Measured: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506:AUC0-∞,Unbound
Area under the unbound plasma concentration-time curve from time 0 to infinity of HS-10506
Measured: Day 1 pre-dose to 120 hours post-dose
Adverse events
Incidence of adverse events
Measured: Screening Day, Day 1 to Day 6
vital signs
Number of participants with abnormal vital signs
Measured: Screening Day, Day 1 to Day 6
Laboratory tests
Number of participants with abnormal laboratory test values
Measured: Screening Day, Day 1 to Day 6
12-lead ECG
Number of participants with abnormal 12-lead ECG findings
Measured: Screening Day, Day 1 to Day 6
Physical examination
Number of participants with abnormal physical examination findings
Measured: Screening Day, Day 1 to Day 6
PK parameter of HS-10506: Vz/F
Apparent volume of distribution during the terminal phase of HS-10506
Measured: Day 1 pre-dose to 120 hours post-dose]
PK parameter of HS-10506: CL/FUnbound
Apparent total clearance of unbound HS-10506
Measured: Day 1 pre-dose to 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Impairment (Moderate or Mild) & Normal Hepatic FunctionStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844967
- Sponsor's protocol ID
- HS-10506-114
- Acronym
- HS-10506-114
- Status last verified
- May 2026
- First submitted
- 8 Jul 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506
- ClinicalTrials.gov ID
- NCT07844967
- Acronym / sponsor ID
- HS-10506-114 / HS-10506-114
- Keywords
- HS-10506, Hepatic Impairment, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Subjects with moderate hepatic impairment | Experimental | Drug: HS-10506 |
| Cohort B: Subjects with normal hepatic function | Active comparator | Drug: HS-10506 |
| Cohort C: Subjects with mild hepatic impairment | Experimental | Drug: HS-10506 |
| Cohort D: Subjects with normal hepatic function | Active comparator | Drug: HS-10506 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Stable hepatic impairment classified as Child-Pugh Class A (mild) and B (moderate) No clinically significant worsening of hepatic status at least 2 months.
- BMI matched with hepatic impairment, mean ±10% Age matched with hepatic impairment, mean ±3 years Gender matched with hepatic impairment
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10506Administered orally | Drug | Cohort A: Subjects with moderate hepatic impairment, Cohort B: Subjects with normal hepatic function, Cohort C: Subjects with mild hepatic impairment, Cohort D: Subjects with normal hepatic function |
Primary outcome
PK parameter of HS-10506: Cmax
Time frame: Day 1 pre-dose to 120 hours post-dose
Maximum observed plasma concentration
PK parameter of HS-10506: AUC0-t
Time frame: Day 1 pre-dose to 120 hours post-dose
Area under the plasma concentration-time curve from time 0 to the last quantifiable time point
PK parameter of HS-10506: AUC0-∞
Time frame: Day 1 pre-dose to 120 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity
14 secondary outcomes
PK parameter of HS-10506: CL/F
Time frame: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506: Tmax
Time frame: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506: t1/2z
Time frame: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506:fu
Time frame: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506:Cmax,Unboundd
Time frame: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506:AUC0-t,Unbound
Time frame: Day 1 pre-dose to 120 hours post-dose
PK parameter of HS-10506:AUC0-∞,Unbound
Time frame: Day 1 pre-dose to 120 hours post-dose
Adverse events
Time frame: Screening Day, Day 1 to Day 6
vital signs
Time frame: Screening Day, Day 1 to Day 6
Laboratory tests
Time frame: Screening Day, Day 1 to Day 6
12-lead ECG
Time frame: Screening Day, Day 1 to Day 6
Physical examination
Time frame: Screening Day, Day 1 to Day 6
PK parameter of HS-10506: Vz/F
Time frame: Day 1 pre-dose to 120 hours post-dose]
PK parameter of HS-10506: CL/FUnbound
Time frame: Day 1 pre-dose to 120 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10506 in people with Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhou, Doctorate (0086-13665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameter of HS-10506: Cmax (time frame: Day 1 pre-dose to 120 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.