NCT06681493

A Phase 1 Study of YZJ-4729 Tartrate Injection in Healthy Chinese Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Analgesia

Interventions

Type	Name	Description
DRUG	YZJ-4729 Tartrate injection	Infusion, QD
DRUG	YZJ-4729 simulated injection	Infusion, QD

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-04-14
• Completion: 2023-09-22
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: China