Phase 1 Open-Label Study on Drug Interactions Among Itraconazole, Rifampin, Midazolam, and SIM0270 in Healthy Chinese Adults Aged 18 to 55

What this Trial Is About

Researchers are conducting an open-label, fixed-sequence Phase 1 clinical trial to study drug interactions in healthy adult Chinese participants. The study plans to enroll three cohorts of 16 to 20 participants each, including both males and females in the first two cohorts and males only in the third. The trial evaluates the effects of itraconazole, rifampin, midazolam, and SIM0270 on each others pharmacokinetics in healthy adults aged 18 to 55 years. Participants receive oral doses of the study drugs in different cohorts Cohort 1 assesses the impact of itraconazole on SIM0270, Cohort 2 evaluates rifampins effect on SIM0270, and Cohort 3 studies how SIM0270 affects midazolam. The study is non-randomized and open-label, with no masking. The treatment periods include multiple days of dosing and follow-up for pharmacokinetic measurements. During the trial, participants undergo various assessments including blood sampling to measure drug concentrations and pharmacokinetic parameters such as maximum concentration, area under the curve, and half-life. Safety evaluations include physical exams, vital signs, ECGs, laboratory tests, and monitoring for adverse effects. The total study duration and detailed monitoring schedules are aligned with the pharmacokinetic sampling days.

An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants