drugset / Trial / NCT05902728

Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects

NCT05902728

Phase 1 Completed 20 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design. Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.

Timeline

Start
2023-07-04
Primary completion
2023-12-19
Completion
2023-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX208 Unknown 450 mg
Subject HLX208 Unknown 900 mg
Subject Itraconazole Small molecule 200 mg
Subject Rifampin Small molecule 600 mg