Non-cystic Fibrosis Bronchiectasis study: HSK31858 tablet vs Moxifloxacin
Official title Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
ClinicalTrials.gov ID: NCT07915024
What this study is testing
What is HSK31858 tablet?
HSK31858 tablet is an investigational medicine, taken by mouth, being studied as a potential treatment for non-cystic fibrosis bronchiectasis (ncfbe).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a concentration-QTc interval clinical study of HSK31858 tablets in healthy people.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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.
- Participants (including their partners) had no plans for having children or donating sperm or eggs during the trial period and within 3 months after...
- Fully understand the purpose, requirements and possible risks of this trial, voluntarily participate in the clinical trial and be able to sign the...
You likely can't join if
- 1) During the screening period or baseline period, if the results of vital signs, physical examination, laboratory tests (blood cell analysis...
- 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...
- 4) Those who are known to be allergic to any component of HSK31858 Tablets, moxifloxacin hydrochloride tablets or similar drugs and their...
- 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...
- 6) Those who have had or are currently suffering from periodontitis, palmoplantar hyperkeratosis, or major/chronic diseases of the cardiovascular...
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 9) Any drugs that inhibit or induce liver CYP enzymes (such as CYP3A4 inducers - rifampicin, dexamethasone, carbamazepine, oxcarbazepine, phenytoin, phenytoin, deoxyphenybital, enzalutamide, St.
- 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...
- 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...
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jinan, Shandong, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.