NCT06522945

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

An Open, Parallel, Single-dose Phase I Clinical Study on the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	TQD3524	Polymyxin antibiotics
DRUG	TQD3524	Polymyxin antibiotics
DRUG	TQD3524	Polymyxin antibiotics
DRUG	TQD3524	Polymyxin antibiotics
DRUG	TQD3524	Polymyxin antibiotics
DRUG	TQD3524	Polymyxin antibiotics

Timeline

• Start date: 2024-07-24
• Primary completion: 2025-12-18
• Completion: 2025-12-18
• First posted: 2024-07-26
• Last updated: 2026-01-09

Locations

1 site across 1 country: China