Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT04352361
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2020-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects
Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of TVB-2640 Tablets in Chinese Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2020-04
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:
Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640 tablets in the Chinese healthy population.
Detailed Description:
This study is designed as a single-center, randomized, single-blind, placebo-controlled, single-dose escalation trial. The dose groups are 25 mg, 50 mg and 75 mg respectively. The next dose should be tested only if the previous dose has demonstrated to be safe and tolerated, and each subject will receive either the experimental drug or a placebo only once.
Study Oversight
Has Oversight DMC:
False
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?: