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drugset / Trial / NCT06681493

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

NCT06681493 ↗

Phase 1 Completed 66 enrolled Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-10-12
Primary completion
2023-04-14
Completion
2023-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject YZJ-4729 Unknown — Other

Indications

No indication recorded.