A Phase 1 interventional study of HSK31858 tablets in Non-cystic Fibrosis Bronchiectasis (NCFBE), sponsored by Haisco Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
The study is being conducted to compare the pharmacokinetics, safety of HSK31858 in subjects with mild, moderate, severe hepatic impairment and normal hepatic function.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 263 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 118 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 (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 (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;
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 measures (for details, see Appendix 3);
Patients with liver dysfunction also need to meet the following inclusion criteria:
9) 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 (, ), 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.
Exclusion Criteria:
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;
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 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 (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: virus surface antigen, virus antibody, 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 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 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 ) or other 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; ≤70 g/L; Those with (ALT) or aspartate aminotransferase (AST) ≥5 times the value (ULN) There was severe active bleeding or level ≤50×109/L ( 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with mild hepatic impairment
Drug: HSK31858 tablets
Subjects with moderate hepatic impairment.
Drug: HSK31858 tablets
Subjects with severe hepatic impairment.
Drug: HSK31858 tablets
Subjects with normal hepatic function.
Drug: HSK31858 tablets
oral
Cmax
The maximum plasma concentration.
Time frame: Post-dose at day 1 to day 14.
AUC0-t
Area under the concentration curve from time 0 to the last quantifiable concentration
Time frame: Post-dose at day 1 to day 14.
AUC0-∞
Area under the concentration curve from time 0 to extrapolated infinite time
Time frame: Post-dose at day 1 to day 14.
AE
Incidence and severity of adverse events
Time frame: Post-dose at day 1 to day 14.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Haisco Pharmaceutical Group Co., Ltd. →