The Safety, Tolerability and Pharmacokinetic Study of ZSP1273 in Healthy Volunteers.

Phase 1 Completed 103 enrolled Guangdong Zhongsheng Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a single center,double-blind,randomized,parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of ZSP1273,and the effect of food on ZSP1273 Pharmacokinetics.

Timeline

Start: 2018-09-20
Primary completion: 2019-03-19
Completion: 2019-04-26

Publications

Hu Y, Li H, Wu M, Zhang H, Ding Y, Peng Y, Li X, Yu Z. Single and multiple dose pharmacokinetics and safety of ZSP1273, an RNA polymerase PB2 protein inhibitor of the influenza A virus: a phase 1 double-blind study in healthy subjects. Expert Opin Investig Drugs. 2021 Nov;30(11):1159-1167. doi: 10.1080/13543784.2021.1994944. Epub 2021 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Onradivir	Small molecule	100 mg	Oral
Subject	Onradivir	Small molecule	200 mg	Oral
Subject	Onradivir	Small molecule	400 mg	Oral
Subject	Onradivir	Small molecule	600 mg	Oral
Subject	Onradivir	Small molecule	900 mg	Oral
Subject	Onradivir	Small molecule	1200 mg	Oral

The Safety, Tolerability and Pharmacokinetic Study of ZSP1273 in Healthy Volunteers.

Summary

Timeline

Publications

Drugs

Indications