drugset
drugset / Trial / NCT05217732

Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers

NCT05217732 ↗

Phase 1 Completed 66 enrolled Nanjing Zenshine Pharmaceuticals
RandomizedSequentialTriple-blindTreatment

Summary

Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending doses of ZX-7101A tablet. Part 2 is to assess the food effect on ZX-7101A at a selected dose in a cross-over design.

Timeline

Start
2021-12-01
Primary completion
2022-08-29
Completion
2022-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject ZX-7101A Unknown — Oral

Indications

No indication recorded.