Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-27 @ 2:46 AM
Study NCT ID:
NCT06681493
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of YZJ-4729 Tartrate Injection in Healthy Chinese Subjects
Sponsor:
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and PK/PD of YZJ-4729 Tartrate Injection After A Single Ascending Dose
Status:
COMPLETED
Status Verified Date:
2024-11
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:
Part A
Primary objective:
• To evaluate the safety, tolerability, and pharmacokinetic profile of a single dose of YZJ-4729 tartrate injection.
Secondary objectives:
* To investigate the PK/PD profile of YZJ-4729 tartrate injection administered as a single dose;
* To investigate the metabolic transformation characteristics of YZJ-4729 tartrate;
* To assess the relationship between plasma concentrations and change in QT interval (C-QT) and the effect on QT interval in subjects after a single dose of YZJ-4729 tartrate injection.
Part B
Primary objective:
• To evaluate the safety, tolerability and pharmacokinetic profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates .
Secondary objectives:
• To investigate the PK/PD profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates.
Primary objective:
• To evaluate the safety, tolerability, and pharmacokinetic profile of a single dose of YZJ-4729 tartrate injection.
Secondary objectives:
* To investigate the PK/PD profile of YZJ-4729 tartrate injection administered as a single dose;
* To investigate the metabolic transformation characteristics of YZJ-4729 tartrate;
* To assess the relationship between plasma concentrations and change in QT interval (C-QT) and the effect on QT interval in subjects after a single dose of YZJ-4729 tartrate injection.
Part B
Primary objective:
• To evaluate the safety, tolerability and pharmacokinetic profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates .
Secondary objectives:
• To investigate the PK/PD profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates.
Detailed Description:
None
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?: