drugset / Trial / NCT03322800

A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers

NCT03322800 ↗

Phase 1 Completed 51 enrolled Shanghai Ark Biopharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will characterize the pharmacokinetics (PK) of AK0529, the effect of food and evaluate the safety of AK0529 in healthy Chinese adult subjects. 50 subjects will be randomized to receive a dose level of AK0529 or placebo in five groups. The total study duration will be approximately 18-27 days for each subject.

Timeline

Start
2017-10-23
Primary completion
2018-04-06
Completion
2018-05-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Ziresovir Small molecule 100 mg Oral
Subject Ziresovir Small molecule 300 mg Oral
Subject Ziresovir Small molecule 600 mg Oral

Indications

No indication recorded.