Non-cystic Fibrosis Bronchiectasis (NCFBE)Phase 1NCT07915024
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
A Phase 1 study testing HSK31858 tablet and Moxifloxacin in people with Non-cystic Fibrosis Bronchiectasis (NCFBE), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is a concentration-QTc interval clinical study of HSK31858 tablets in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis (NCFBE)
- What is being tested?
- HSK31858 tablet and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At the time of screening, the age should be between 18 and 45 years old (including the boundary value), and healthy male or female.
- When screening, the weight of men should be ≥50kg and that of women ≥45kg. And the body mass index (BMI= weight (kg)/height (m2)) is within the range of 19.0 to 26.0 kg/m2 (including the boundary value);
- Participants (including their partners) had no plans for having children or donating sperm or eggs during the trial period and within 3 months after the last administration, and agreed to take effective contraceptive measures (for details, see Appendix 1);
- Fully understand the purpose, requirements and possible risks of this trial, voluntarily participate in the clinical trial and be able to sign the informed consent form before the trial commences
Who cannot join
- 1) During the screening period or baseline period, if the results of vital signs, physical examination, laboratory tests (blood cell analysis (five-category), blood biochemistry, coagulation function, urine routine test plus sediment), frontal or lateral chest X-rays or CT, ultrasound examination, etc. are abnormal and of clinical significance, or if physical examination reveals tattoos or scars on any part of the skin that affect safety evaluation;
- 2) Abnormal electrocardiogram (ECG) results during the screening period or baseline period with clinical significance, or QTcF\> 450ms;
- 3) Those who test positive for any one of the following: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or Treponema pallidum antibody during the screening period;
- 4) Those who are known to be allergic to any component of HSK31858 Tablets, moxifloxacin hydrochloride tablets or similar drugs and their preparations, or those with an allergic constitution (such as allergic to two or more substances); Or those with a specific history of allergies (such as asthma, urticaria, eczema, etc.);
- 5) There is a history of any type of cardiovascular disease/disorder/surgery that may increase the possibility of prolonged QT interval or other risk factors for torus pointes ventricular tachycardia (such as heart failure, hypokalemia, hypomagnemia, congenital long QT syndrome or a family history of long QT syndrome, etc.);
- 6) Those who have had or are currently suffering from periodontitis, palmoplantar hyperkeratosis, or major/chronic diseases of the cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune, skin, nervous systems, etc., or have any other diseases during the screening period;
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- 7) Those who have donated blood or lost blood of ≥400 mL within 3 months prior to screening, or have donated blood during the planned study period, or have received blood transfusion or used blood products within 3 months prior to screening;
- 8) Those who have previously undergone diseases or surgeries that could interfere with drug absorption, distribution, metabolism or excretion (such as gastrointestinal resection), or those who have undergone major surgeries within 3 months prior to the screening period or whose surgical incisions have not fully healed;
- 9) Any drugs that inhibit or induce liver CYP enzymes (such as CYP3A4 inducers - rifampicin, dexamethasone, carbamazepine, oxcarbazepine, phenytoin, phenytoin, deoxyphenybital, enzalutamide, St. John's wort, etc.) have been used within 28 days before screening or within 5 half-lives of the drugs (whichever is longer). CYP3A4 inhibitors such as itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, ritonavir, etc., or any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements other than the above-mentioned drugs have been taken within 14 days before screening or within 5 half-lives (whichever is longer) of the drug.
- 10) Those who have participated in other drug clinical trials and used the investigational drug within 3 months 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); Or those who plan to participate in other clinical trials during the trial period;
- 11) Those who have received a live vaccine (except for the influenza vaccine) within one month before screening or plan to receive a live vaccine during the trial period;
- 12) Those with a history of drug abuse, drug abuse or drug dependence, or with a positive screening result for drug abuse;
- 13) Those who frequently consumed alcohol within the three months prior to screening, that is, those who consumed more than 14 units of alcohol per week (1 unit =360mL of beer or 45mL of 40% alcohol spirit or 150 ml of wine), or those who were unable to ablate alcohol during the test period, or those with a positive breath test for alcohol;
- 14) The average daily smoking (or the use of an equivalent amount of nicotine-containing products) in the three months prior to screening was more than five cigarettes, or smoking was not allowed during the trial period;
- 15) 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;
- 16) 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;
- 17) Those with a history of difficulty in venous blood collection, fainting at the sight of needles or blood, or those with poor venous assessment or inability to tolerate venous puncture blood collection;
- 18) Those who have special dietary requirements and cannot follow a uniform diet; Or those who have difficulty swallowing;
- 19) Pregnant or lactating women, or those whose pregnancy test results exceed the upper limit of the normal value, or female participants who engaged in non-protective sexual behavior two weeks before screening;
- 20) Participants who the researchers consider to have poor compliance or other factors that make them unsuitable for participating in this trial.
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
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong
Wei Zhao, 0531-89268212, zhao4wei2@hotmail.com
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled and Active-Controlled (Open-Label) Phase I Clinical Trial to Evaluate the Effect of Single Oral Administration of HSK31858 Tablets on QTc Interval in Healthy Chinese Participants
This study is a concentration-QTc interval clinical study of HSK31858 tablets in healthy participants.
- Being tested
- HSK31858 tablet, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK31858 tabletDrug
oral
PlaceboDrug
oral
MoxifloxacinDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| HSK31858 Single Ascending Dose | Experimental | A single dose of HSK31858 tablet Receives: Drug: HSK31858 tablet; Drug: Placebo; Drug: Moxifloxacin |
| HSK31858 Multiple Doses | Experimental | Multiple doses of HSK31858 tablet Receives: Drug: HSK31858 tablet; Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of QTc interval
Effect of HSK31858 plasma concentrations on the QTc interval.
Measured: Baseline, Day14, Day28
Secondary outcomes (1)
Adverse events
Safety and tolerability of HSK31858 after single or multiple doses
Measured: Day14, Day28
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 start6 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 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
- NCT07915024
- Sponsor's protocol ID
- HSK31858-108
- 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
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
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled and Active-Controlled (Open-Label) Phase I Clinical Trial to Evaluate the Effect of Single Oral Administration of HSK31858 Tablets on QTc Interval in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07915024
- Acronym / sponsor ID
- HSK31858-108
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 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.
This study is a concentration-QTc interval clinical study of HSK31858 tablets in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK31858 Single Ascending Dose | Experimental | Drug: HSK31858 tablet, Drug: Placebo, Drug: MoxifloxacinA single dose of HSK31858 tablet |
| HSK31858 Multiple Doses | Experimental | Drug: HSK31858 tablet, Drug: Placebo, Drug: MoxifloxacinMultiple doses of HSK31858 tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At the time of screening, the age should be between 18 and 45 years old (including the boundary value), and healthy male or female.
- When screening, the weight of men should be ≥50kg and that of women ≥45kg. And the body mass index (BMI= weight (kg)/height (m2)) is within the range of 19.0 to 26.0 kg/m2 (including the boundary value);
- Participants (including their partners) had no plans for having children or donating sperm or eggs during the trial period and within 3 months after the last administration, and agreed to take effective contraceptive measures (for details, see Appendix 1);
- Fully understand the purpose, requirements and possible risks of this trial, voluntarily participate in the clinical trial and be able to sign the informed consent form before the trial commences
Key exclusion criteria (20 listed)
- 1) During the screening period or baseline period, if the results of vital signs, physical examination, laboratory tests (blood cell analysis (five-category), blood biochemistry, coagulation function, urine routine test plus sediment), frontal or lateral chest X-rays or CT, ultrasound examination, etc. are abnormal and of clinical significance, or if physical examination reveals tattoos or scars on any part of the skin that affect safety evaluation;
- 2) Abnormal electrocardiogram (ECG) results during the screening period or baseline period with clinical significance, or QTcF\> 450ms;
- 3) Those who test positive for any one of the following: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or Treponema pallidum antibody during the screening period;
- 4) Those who are known to be allergic to any component of HSK31858 Tablets, moxifloxacin hydrochloride tablets or similar drugs and their preparations, or those with an allergic constitution (such as allergic to two or more substances); Or those with a specific history of allergies (such as asthma, urticaria, eczema, etc.);
- 5) There is a history of any type of cardiovascular disease/disorder/surgery that may increase the possibility of prolonged QT interval or other risk factors for torus pointes ventricular tachycardia (such as heart failure, hypokalemia, hypomagnemia, congenital long QT syndrome or a family history of long QT syndrome, 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 tabletoral | Drug | HSK31858 Multiple Doses, HSK31858 Single Ascending Dose |
| Placebooral | Drug | HSK31858 Multiple Doses, HSK31858 Single Ascending Dose |
| Moxifloxacinoral | Drug | HSK31858 Multiple Doses, HSK31858 Single Ascending Dose |
Primary outcome
Changes of QTc interval
Time frame: Baseline, Day14, Day28
Effect of HSK31858 plasma concentrations on the QTc interval.
1 secondary outcome
Adverse events
Time frame: Day14, Day28
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.
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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 tablet and Moxifloxacin 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 4 inclusion and 20 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?
Changes of QTc interval (time frame: Baseline, Day14, Day28). 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.