A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects (NCT06387966) | Clinical Trial Compass
CompletedPhase 1
A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects
China40 participantsStarted 2024-03-18
Plain-language summary
Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo group, conduct single oral administration safety and tolerability test group by group.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Age and gender: 18 to 45 years old (including 18 and 45 years old), no gender limit;
✓. The weight of male subjects is ≥50.0 kg, the weight of female subjects is ≥45.0 kg, and the body mass index (BMI) is between 19.0 and 25.0 kg/m2 (including the boundary value);
✓. Those who fully understand the trial content, trial drugs, trial process, etc., can communicate well with the researchers, are willing to comply with the research regulations, voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
✕. Those with a history of severe allergies (such as angioedema and anaphylactic shock), allergies (such as allergies to pollen, two or more drugs/foods), or those with Those who are judged by the researcher to have a clinically significant history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.); or those who are known to be allergic to JAK inhibitors or to excipients contained in the trial drug ;
✕. QTcF \> 440 ms for males and \> 460 ms for females on ECG during the screening period;
✕. Those who have undergone major surgical operations within 3 months before screening or plan to undergo surgery during the trial;
✕. Those who suffer from acute diseases within 2 weeks before screening; those who have clinically significant infections (such as upper respiratory tract infection, nasopharyngitis, urinary system infection, etc.) within 3 months before screening; those who have any symptoms within 7 days before screening Those with evidence of infection; those with a history of herpes simplex infection or recurrent (\>1) herpes zoster or disseminated herpes zoster.
✕. Have any history of serious clinical diseases or diseases or conditions that the researcher believes may affect the test results, including but not limited to the circulatory system, endocrine system, nervous system, digestive system, urinary system or History of blood, immune, psychiatric and metabolic diseases;
✕. Those with a history of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption;
✕. Those with irregular bowel movements and habitual constipation or diarrhea;