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

NCT06681493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-11-08

No results posted yet for this study

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

DRUG

YZJ-4729 Tartrate injection

Infusion, QD

DRUG

YZJ-4729 simulated injection

Infusion, QD

Sponsors & Collaborators

  • Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06681493 on ClinicalTrials.gov