Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 12:30 AM
Study NCT ID:
NCT07123428
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single and Multiple Ascending Doses and Food Effect Study of TRD205 in Healthy Volunteers
Sponsor:
Beijing Tide Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of and Food Effect on TRD205 After Single and Multiple Doses in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2025-08
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:
This is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of TRD205 after single and multiple doses and to evaluate the effect of food on TRD205 in healthy adult subjects.
Detailed Description:
This study consists of three parts:
* Single ascending dose study
* Multiple ascending dose study
* Food effect study
* Single ascending dose study
* Multiple ascending dose study
* Food effect study
Study Oversight
Has Oversight DMC:
None
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?: