Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Expression Inhibitor GST-HG131 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial
Xiaojiao Li, Yusi Liu, Hanxin Yao, Meng Wang, Lei Gao, Jinfeng Lou, John Mao, Wenqiang Wu, Yixin Zhou, Yanan Tang, Wenhao Yan, Yanbin Hu, Charles Z. Ding, Shuhui Chen, Junqi Niu, Yanhua Ding
Abstract
< 1.5). In conclusion, GST-HG131 exhibited an acceptable safety profile in healthy subjects at single doses ranging from 10-300 mg and multiple doses (BID) ranging from 30-60 mg, and the MAD doses (30 mg and 60 mg BID) that potentially meet the therapeutic AUC requirements. These findings imply GST-HG131 has potential as a therapeutic option for CHB infection. (This study has been registered at ClinicalTrials.gov under identifier NCT04499443.).
Topics & Concepts
TolerabilityPharmacokineticsPlaceboAdverse effectMedicineDosingNauseaPharmacologyGastroenterologyInternal medicineVomitingPathologyAlternative medicineHepatitis B Virus StudiesHepatitis C virus researchHIV/AIDS drug development and treatment