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COMPLETED
NCT06681493
PHASE1

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

Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2022-10-12

Completion Date

2023-09-22

Last Updated

2026-06-30

Healthy Volunteers

No

Interventions

DRUG

YZJ-4729 Tartrate injection

Infusion, QD

DRUG

YZJ-4729 simulated injection

Infusion, QD

Locations (1)

Xiangya Third Hospital, Central South University

Changsha, China