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To Evaluate the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects

NCT06522945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-09

No results posted yet for this study

Summary

This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the urinary excretion of the drug in these patients after a single dose, as well as to evaluate the safety of the drug in these patients after a single dose.

Conditions

  • Multi-resistant Gram-negative Bacteria Cause Infection

Interventions

DRUG

TQD3524

Polymyxin antibiotics

DRUG

TQD3524

Polymyxin antibiotics

DRUG

TQD3524

Polymyxin antibiotics

DRUG

TQD3524

Polymyxin antibiotics

DRUG

TQD3524

Polymyxin antibiotics

DRUG

TQD3524

Polymyxin antibiotics

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2025-12-18
Completion
2025-12-18

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 NCT06522945 on ClinicalTrials.gov