Non-cystic Fibrosis Bronchiectasis (NCFBE)Phase 1NCT07913009
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
A Phase 1 study testing HSK31858 tablets in people with Non-cystic Fibrosis Bronchiectasis (NCFBE), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to compare the pharmacokinetics, safety of HSK31858 in subjects with mild, moderate, severe hepatic impairment and normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis (NCFBE)
- What is being tested?
- HSK31858 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to Jan 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Participants can understand the nature, purpose, procedures, possible risks and adverse reactions of this trial, and complete the trial as required. Voluntarily participate in clinical trials and sign the informed consent form before the trial commences;
- 2) Male or female participants aged 18 to 70 years old on the day of signing the informed consent form (including the cut-off value);
- 3) When screening, the weight of men should be ≥50kg and that of women ≥45kg. The body mass index (BMI= weight (kg)/height (m ²)) is within the range of 18.0 to 32.0 kg/m ² (including the critical value);
- 4) The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI 2021 formula (see Annex 2) is ≥ 75 mL/min/1.73m2;
- 5) At the time of screening, the normal or abnormal results of vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), frontal chest X-ray or CT, and abdominal color Doppler ultrasound of the participants in the normal liver function group had no clinical significance;
- 6) Participants with normal liver function and no previous serious primary diseases of vital organs, including but not limited to circulatory system, coagulation system, endocrine system, skin system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities;
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- 7) The demographic mean of participants in the normal liver function group at the time of screening must meet the following matching criteria: a) BMI matching was conducted with the liver dysfunction group, with the mean value within ±15% (including the critical value); b) Age matching was carried out with the liver dysfunction group, with the mean value within ±10 years (including the critical value); c) Gender matching was conducted with the liver dysfunction group, with ±1 participant/gender.
- 8) Participants (including their partners) had no plans for having children, no plans for sperm or egg donation during the trial period and within 3 months after administration, and agreed to take effective contraceptive measures (for details, see Appendix 3);
- Patients with liver dysfunction also need to meet the following inclusion criteria:
- 9) Child-Pugh grade A, B and C liver insufficiency (without albumin use within 14 days), chronic liver injury caused by previous primary liver diseases: including but not limited to non-alcoholic steatohepatitis, viral hepatitis (hepatitis B, hepatitis C), etc.
- 10) Within 4 weeks before administration, the researcher determined that the liver function was stable based on clinical manifestations (Child-Pugh grade A and B); Within 2 weeks before administration, the researchers determined that the liver function was stable based on clinical manifestations (Child-Pugh grade C).
- 11) Those who have not taken medication within the 4 weeks prior to screening, or have a stable medication regimen for at least 4 weeks for primary liver diseases.
Who cannot join
- 1) Those who are known to be allergic to any component of the test drug or preparation, or those with an allergic constitution (such as being allergic to two or more drugs, foods or pollen, etc.);
- 2) Those who have special dietary requirements and cannot accept a uniform diet; Or those who have difficulty swallowing;
- 3) The average daily smoking (or the use of an equivalent amount of nicotine-containing products) within the three months prior to screening was more than five cigarettes, or smoking could not be prohibited during the trial period;
- 4) Those who have a history of alcohol abuse within the three months prior to screening, that is, those who consume more than 14 units of alcohol per week (1 unit =360mL of beer or 45 ml of 40% alcohol or 150 ml of wine), or those who cannot abban alcohol during the test period, or those with a positive breath test for alcohol;
- 5) Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 4 cups per day, 1 cup =250mL) within the three months prior to screening; Or those who have consumed tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours before the first administration; Or disagree to stop taking tea, coffee or foods or beverages containing caffeine during the trial period;
- 6) Those who have consumed a large amount of beverages or foods rich in grapefruit (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; Or those who have consumed any beverage or food rich in grapefruit (i.e. grapefruit) within 48 hours before the first administration; Or those who do not agree to stop drinking any beverages or foods rich in grapefruit (i.e. grapefruit) during the trial period;
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- 7) Previously diagnosed as a malignant tumor (excluding radical resection of cutaneous basal cell carcinoma, papillary thyroid carcinoma, cutaneous squamous cell carcinoma or cervical cancer in situ);
- 8) Participants previously diagnosed with periodontitis or/and palmoplantar hyperkeratosis;
- 9) Those with a history of drug abuse, drug abuse or drug dependence, or with a positive screening result for drug abuse;
- 10) There are obvious factors or gastrointestinal diseases that significantly affect the absorption of oral drugs, such as inability to take oral drugs or obvious nausea and vomiting, malabsorption, external biliary drainage, gastrointestinal resection, etc.
- 11) Those who have donated blood or lost blood of ≥400mL within the 3 months prior to screening (excluding menstrual blood loss in women) or donated blood during the planned study period;
- 12) Those who have used any drugs that inhibit or induce liver CYP enzymes within 28 days before screening or within 5 half-lives of the drugs (whichever is longer);
- 13) Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 14 days prior to the administration of the investigational drug or within 5 half-lives (whichever is longer) of the drug (only participants with normal liver function);
- 14) Those who have participated in any clinical trial of a drug or medical device within 3 months prior to screening and are expected to have residual effects of the trial treatment (as determined by the investigator), or are still within the follow-up period of a certain clinical trial or within 5 half-lives of the trial drug before screening (whichever is longer);
- 15) Those who have received live vaccines (excluding influenza vaccines) within one month prior to screening or plan to receive attenuated live vaccines during the trial period;
- 16) Those who test positive for any one of the following indicators during the screening period: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody (positive results for hepatitis B virus surface antigen and hepatitis C virus antibody are acceptable for participants in the liver dysfunction group).
- 17) The QTcF interval during the screening period (calculated by the formula QTcF = QT/RR0.33) is for males ≥470ms and females ≥480ms, or for those whose abnormalities are clinically significant as determined by the investigators and who are not suitable for this trial as determined by the investigators.
- 18) Those who have had systemic active infections (such as respiratory or central nervous system infections, etc.), severe trauma, or major surgical operations within two weeks prior to screening;
- 19) Those who are expected to have a tendency towards surgery or hospitalization other than those required by the trial during the trial period; Or participants who are expected not to complete the entire follow-up of the trial;
- 20) Those with a history of fainting at the sight of needles or blood, those who have difficulty in blood collection or cannot tolerate venipuncture blood collection, or those whose physical condition cannot tolerate blood collection;
- 21) Researchers determine that there are tattoos or scars on any part of the skin that affect the safety assessment.
- 22) Pregnant or lactating women; Or those with positive results in pregnancy tests;
- 23) Participants who were considered by the researchers to have poor compliance or other factors that made them unsuitable for this trial.
- For patients with liver dysfunction, the following exclusion criteria should also be added:
- 24) In addition to the primary liver disease itself, there is any history of serious diseases, or any medical history and/or clinical laboratory tests of clinical significance that the researcher believes may affect the test results, including but not limited to a history of circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;
- 25) Patients currently in a state of acute liver failure Or cirrhotic patients with drug-induced liver injury, hepatic encephalopathy (Westhaven grade 2 or above), hepatocellular carcinoma (excluding those with Barcelona stage 0 or those who have achieved radical treatment), current patients with esophageal and gastric variceal bleeding, or those who have undergone portosystemic shunt within half a year and other complications considered unsuitable by researchers; 26) Participants who had been using systemic hormones (excluding those stably using prednisone at a dose of ≤ 5 mg/ day or an equivalent dose of glucocorticoids) or other immunosuppressants within 4 weeks before screening, or those who were still within the drug efficacy period more than 4 weeks after the last immunosuppressive treatment at the time of screening (as evaluated by the investigators);
- 27) Alpha-fetoprotein \> 20 ng/mL; Hemoglobin ≤70 g/L; Those with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 times the upper limit of the normal value (ULN) There was severe active bleeding or platelet level ≤50×109/L (Child-Pugh grade A, B) or platelet level ≤30×109/L (Child-Pugh grade C) during screening (except for cases judged by the researcher to be in a stable state);
- 28) Has a history of liver transplantation.
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
Henan Infectious Disease Hospital (Zhengzhou No.6 People's Hospital)
Zhenzhou, Henan
Shuang Li, 13938529645, li36918@163.com
About this study
Official title: An Open-Label Phase I Clinical Study to Compare the Pharmacokinetics and Safety Profile of Single Oral Administration of HSK31858 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function
The study is being conducted to compare the pharmacokinetics, safety of HSK31858 in subjects with mild, moderate, severe hepatic impairment and normal hepatic function.
- Being tested
- HSK31858 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK31858 tabletsDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Subjects with mild hepatic impairment Receives: Drug: HSK31858 tablets |
| Treatment group B | Experimental | Subjects with moderate hepatic impairment. Receives: Drug: HSK31858 tablets |
| Treatment group C | Experimental | Subjects with severe hepatic impairment. Receives: Drug: HSK31858 tablets |
| Treatment group D | Experimental | Subjects with normal hepatic function. Receives: Drug: HSK31858 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum plasma concentration.
Measured: Post-dose at day 1 to day 14.
AUC0-t
Area under the concentration curve from time 0 to the last quantifiable concentration
Measured: Post-dose at day 1 to day 14.
AUC0-∞
Area under the concentration curve from time 0 to extrapolated infinite time
Measured: Post-dose at day 1 to day 14.
Secondary outcomes (1)
AE
Incidence and severity of adverse events
Measured: Post-dose at day 1 to day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start16 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis Bronchiectasis (NCFBE)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913009
- Sponsor's protocol ID
- HSK31858-106
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I Clinical Study to Compare the Pharmacokinetics and Safety Profile of Single Oral Administration of HSK31858 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07913009
- Acronym / sponsor ID
- HSK31858-106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Nov 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.
The study is being conducted to compare the pharmacokinetics, safety of HSK31858 in subjects with mild, moderate, severe hepatic impairment and normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HSK31858 tabletsSubjects with mild hepatic impairment |
| Treatment group B | Experimental | Drug: HSK31858 tabletsSubjects with moderate hepatic impairment. |
| Treatment group C | Experimental | Drug: HSK31858 tabletsSubjects with severe hepatic impairment. |
| Treatment group D | Experimental | Drug: HSK31858 tabletsSubjects with normal hepatic function. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1) Participants can understand the nature, purpose, procedures, possible risks and adverse reactions of this trial, and complete the trial as required. Voluntarily participate in clinical trials and sign the informed consent form before the trial commences;
- 2) Male or female participants aged 18 to 70 years old on the day of signing the informed consent form (including the cut-off value);
- 3) When screening, the weight of men should be ≥50kg and that of women ≥45kg. The body mass index (BMI= weight (kg)/height (m ²)) is within the range of 18.0 to 32.0 kg/m ² (including the critical value);
- 4) The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI 2021 formula (see Annex 2) is ≥ 75 mL/min/1.73m2;
- 5) At the time of screening, the normal or abnormal results of vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), frontal chest X-ray or CT, and abdominal color Doppler ultrasound of the participants in the normal liver function group had no clinical significance;
Key exclusion criteria (28 listed)
- 1) Those who are known to be allergic to any component of the test drug or preparation, or those with an allergic constitution (such as being allergic to two or more drugs, foods or pollen, etc.);
- 2) Those who have special dietary requirements and cannot accept a uniform diet; Or those who have difficulty swallowing;
- 3) The average daily smoking (or the use of an equivalent amount of nicotine-containing products) within the three months prior to screening was more than five cigarettes, or smoking could not be prohibited during the trial period;
- 4) Those who have a history of alcohol abuse within the three months prior to screening, that is, those who consume more than 14 units of alcohol per week (1 unit =360mL of beer or 45 ml of 40% alcohol or 150 ml of wine), or those who cannot abban alcohol during the test period, or those with a positive breath test for alcohol;
- 5) Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 4 cups per day, 1 cup =250mL) within the three months prior to screening; Or those who have consumed tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours before the first administration; Or disagree to stop taking tea, coffee or foods or beverages containing caffeine during the trial period;
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 |
|---|---|---|
| HSK31858 tabletsoral | Drug | Treatment group A, Treatment group B, Treatment group C, Treatment group D |
Primary outcome
Cmax
Time frame: Post-dose at day 1 to day 14.
The maximum plasma concentration.
AUC0-t
Time frame: Post-dose at day 1 to day 14.
Area under the concentration curve from time 0 to the last quantifiable concentration
AUC0-∞
Time frame: Post-dose at day 1 to day 14.
Area under the concentration curve from time 0 to extrapolated infinite time
1 secondary outcome
AE
Time frame: Post-dose at day 1 to day 14.
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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 HSK31858 tablets in people with Non-cystic Fibrosis Bronchiectasis (NCFBE), run by Haisco Pharmaceutical Group 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 12 inclusion and 28 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 3 Nov 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 Meixia Chen (028-67258779, chenmeixia@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Post-dose at day 1 to day 14.). 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 3 Nov 2026.