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, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
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 renal impairment and normal renal function.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
This study's planned enrollment of 24 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 using the CKD-EPI 2021 formula meets the renal function classification criteria of the corresponding group; That is, mild renal insufficiency: 60≤eGFR\< 90 mL/min, moderate renal insufficiency: 30≤eGFR\<" 60 mL/min, severe renal insufficiency: eGFR\<" 30 mL/min without dialysis, normal renal function: 90≤eGFR\<" 130 mL/min;
5) The two eGFR results during the screening period and the baseline period (CKD-EPI 2021 formula, with an interval of ≥72 hours between the two) must be within the same renal function classification.
6) Participants with normal renal 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) 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 chest CT and abdominal color Doppler ultrasound of the participants in the normal renal function group had no clinical significance.
8) For the renal insufficiency group, the researcher evaluated and diagnosed it as chronic kidney disease (with any indicators of renal damage or eGFR less than 60 mL/min for more than 3 months) and/or having stable renal function;
9) For the renal insufficiency group, no new prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products were used within two weeks prior to screening, in addition to the treatment plans already used for the primary disease. Those who had stable medication for renal insufficiency for at least 4 weeks before screening (as determined by the researcher, excluding drugs in the treatment plan) and did not change the treatment plan during the study period;
10) The demographic mean of participants in the normal renal function group at the time of screening must meet the following matching criteria: a) BMI matching was conducted with the renal insufficiency group, with the mean within ±20% (including the critical value); b) Age matching was carried out with the renal insufficiency group, with the mean within ±10 years (including the critical value); c) Gender matching was conducted with the renal insufficiency group, with ±1 participant/gender.
11) 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 2).
Exclusion Criteria:
1) Those who are known to be allergic to any component of the 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) 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);
4) Participants previously diagnosed with periodontitis or/and palmoplantar hyperkeratosis, and with the following conditions at the time of screening: Participants currently showing signs of gingivitis/periodontitis; or Participants with a history of hyperkeratosis or erythema on the palm or sole of the foot;
5) There are obvious factors or gastrointestinal diseases that significantly affect the absorption of oral medications, such as inability to take oral medications or obvious nausea and vomiting, malabsorption, external biliary drainage, gastrointestinal resection, etc.
6) 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;
7) Those with and/or AST > 1.5×, or total > 1.5×ULN during screening; However, those who are assessed by the researchers as eligible to continue the experiment are excluded.
8) The interval during the screening period (calculated by the formula QTcF = QT/RR0.33) was greater than 450ms for men and 470ms for women, or those whose abnormalities were as determined by the investigators and were deemed unsuitable for this trial by the investigators.
9) The average daily smoking (or use of an equivalent amount of nicotine-containing products) in the three months prior to screening was more than five cigarettes, or smoking could not be prohibited during the trial period;
10) 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 45mL of 40% alcohol spirits or 150 ml of wine), or those who cannot abt alcohol during the test period, or those with a positive breath test for alcohol;
11) 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;
12) 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;
13) Those with a history of drug abuse, drug abuse or drug dependence, or with a positive screening result for drug abuse;
14) 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;
15) Those who have used any strong suppressor or strong inducer of within 28 days before screening or within 5 half-lives of the drug (whichever is longer);
16) 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 of the drug (whichever is longer) (only participants with normal renal function, excluding );
17) Those who have participated in any clinical trial of a drug or medical device within 90 days prior to screening, or are still within the follow-up period of a certain clinical trial or within 5 half-lives of the investigational drug before screening (whichever is longer);
18) Those who have received (excluding influenza vaccines) within one month prior to screening or plan to receive attenuated live vaccines during the trial period;
19) Those who have had infections using systemic anti-infective drugs (such as respiratory or central nervous system infections, etc.), severe trauma, or major surgical operations within two weeks prior to screening;
20) Those who are expected to have a tendency towards surgery or hospitalization other than those required by the trial during the trial period;
21) 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;
22) Researchers determine that there are tattoos or scars on any part of the skin that affect the safety assessment.
23) Pregnant or lactating women; Or those with positive results in pregnancy tests;
24) Participants who the researchers consider to have poor compliance or other factors that make them unsuitable for this trial;
For patients with renal insufficiency, the following exclusion criteria should also be added:
25) Those who have received any drugs known to affect serum creatinine (such as glycopeptide antibiotics, aminoglycoside antibiotics, etc.) within 28 days before screening or within 5 half-lives of the drugs (whichever is longer), or those who are expected to take the above drugs during the trial period;
26) during screening 90g/L; Triglycerides during screening > 2.3 mmol/L;
27) For patients with chronic diseases such as hypertension, diabetes, and hyperuricemia, who remain unstable after drug treatment (blood pressure ≥160/100 MMHG, > 9.0%, blood uric acid level ≥480 μmol/L), and whom the researchers consider to be at risk for inclusion in this trial; Those who have experienced acute cardiovascular and cerebrovascular diseases (such as acute myocardial infarction, cerebral infarction, etc.) within half a year;
28) Those who need renal dialysis during the study period or have undergone dialysis (including peritoneal dialysis) within the past year;
29) Those with acute kidney injury or acute renal failure; Those with urinary incontinence or anuria;
30) Those who have received kidney transplants
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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 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.
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.
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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 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).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with mild renal impairment
Drug: HSK31858 tablets
Subjects with moderate renal impairment
Drug: HSK31858 tablets
Subjects with severe renal impairment
Drug: HSK31858 tablets
Subjects with normal renal function
Drug: HSK31858 tablets
oral
Cmax
The maximum plasma concentration
Time frame: 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: 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: Time Frame: Post-dose at day 1 to day 14
Adverse events
Incidence and severity of adverse events
Time frame: Time Frame: Post-dose at day 1 to day 14
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Haisco Pharmaceutical Group Co., Ltd. →