Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-01 @ 3:02 PM
Study NCT ID:
NCT05217732
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2022-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Sponsor:
Nanjing Zenshine Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: