NCT05217732

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety Issues
• Tolerance
• Pharmacokinetics
• Food Effect

Interventions

Type	Name	Description
DRUG	ZX-7101A	tablet
DRUG	Placebo	Tablet

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-08-29
• Completion: 2022-12-19
• First posted: 2022-02-01
• Last updated: 2023-07-21

Locations

1 site across 1 country: China