Non-cystic Fibrosis Bronchiectasis (NCFBE)Phase 1NCT07915011
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal 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 renal impairment and normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 May 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
- Healthy volunteers accepted
- 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 eGFR 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;
Show all 11Show fewer
- 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 contraindicated 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 contraceptive measures (for details, see Appendix 2).
Who cannot join
- 1) Those who are known to be allergic to any component of the investigational 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: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody;
Show all 31Show fewer
- 7) Those with ALT and/or AST > 1.5×ULN, or total bilirubin > 1.5×ULN during screening; However, those who are assessed by the researchers as eligible to continue the experiment are excluded.
- 8) The QTcF 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 clinically significant 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 CYP3A 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 contraceptives);
- 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 live vaccines (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) Hemoglobin 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, glycated hemoglobin > 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
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
Huashan Hospital Fudan University
Zhenzhou, Henan
About this study
Official title: An Open-Label Phase I Study to Compare the Pharmacokinetic and Safety Profiles of a Single Oral Dose of HSK31858 Tablets in Participants With Renal Impairment and Normal Renal Function
The study is being conducted to compare the pharmacokinetics, safety of HSK31858 in subjects with mild, moderate, severe renal impairment and normal renal 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 renal impairment Receives: Drug: HSK31858 tablets |
| Treatment group B | Experimental | Subjects with moderate renal impairment Receives: Drug: HSK31858 tablets |
| Treatment group C | Experimental | Subjects with severe renal impairment Receives: Drug: HSK31858 tablets |
| Treatment group D | Experimental | Subjects with normal renal 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: 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
Measured: Time Frame: Post-dose at day 1 to day 14
AUC0-∞
Area under the concentration curve from time 0 to extrapolated infinite time
Measured: Time Frame: Post-dose at day 1 to day 14
Secondary outcomes (1)
Adverse events
Incidence and severity of adverse events
Measured: Time Frame: 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 posted4 Nov 2026
- Study start26 May 2026
- Primary completionNov 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
- 24 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
- NCT07915011
- Sponsor's protocol ID
- HSK31858-107
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I Study to Compare the Pharmacokinetic and Safety Profiles of a Single Oral Dose of HSK31858 Tablets in Participants With Renal Impairment and Normal Renal Function
- ClinicalTrials.gov ID
- NCT07915011
- Acronym / sponsor ID
- HSK31858-107
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 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 renal impairment and normal renal 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 renal impairment |
| Treatment group B | Experimental | Drug: HSK31858 tabletsSubjects with moderate renal impairment |
| Treatment group C | Experimental | Drug: HSK31858 tabletsSubjects with severe renal impairment |
| Treatment group D | Experimental | Drug: HSK31858 tabletsSubjects with normal renal function |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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 eGFR 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.
Key exclusion criteria (31 listed)
- 1) Those who are known to be allergic to any component of the investigational 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.
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: Time Frame: Post-dose at day 1 to day 14
The maximum plasma concentration
AUC0-t
Time frame: 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: 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
Adverse events
Time frame: 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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Active, not recruitingObservational study
A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE
Non-cystic Fibrosis Bronchiectasis
Not yet recruitingObservational study
Observational Study of Sputum Inflammation Phenotypes and Clinical Outcomes in Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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 11 inclusion and 31 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 4 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: 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 4 Nov 2026.