This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.
The participant fully understand the test content, process and possible adverse reactions, voluntarily sign informed consent, have good communication with the researchers, and can complete all the test procedures in accordance with the protocol.
Cohorts 1 and 2: healthy male and female participants aged ≥ 18 and ≤ 55 years; Cohort 3: healthy male participants aged ≥ 18 and ≤ 55 years.
Male participants weigh ≥ 50 kg; Female participants weigh ≥ 45 kg; Body mass index ≥ 19 kg/m2 and ≤ 26 kg/m2.
Cohorts 1 and 2: all female participants of childbearing potential and male participants with partners of women of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent; Cohort 3: male participants with partners of women of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent.
Neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, skeletal-muscular disorders, especially hepatic and renal insufficiency, or any other disease and condition that may affect the results of the study or the safety of the participants.
History of dysphagia or any gastrointestinal disorder affecting drug absorption.
Presence of risk factors for Torsade de Pointes (e.g., history of heart failure, hypokalemia, family history of QT prolongation syndrome), or other clinically significant abnormalities judged by the study doctor (including but not limited to: complete left bundle branch block; right bundle branch block; first-, second-, or third-degree heart block; sick sinus syndrome or previous history of myocardial infarction).
History of active or latent tuberculosis.
Sequential
SIM0270
Drugoral
itraconazole
Drugoral
Rifampin
Drugoral
midazolam
Drugoral
Maximum observed concentration (Cmax) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration-time curve from time 0 to tau (AUC0-tau) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Click on the lead sponsor to view all of their trials.
