NCT06672276

To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency

An Open, Parallel, Single-dose Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The study is an open, parallel, single-dose phase I clinical study to evaluate the pharmacokinetics and safety of TQD3606 for injection in subjects with renal insufficiency.

Conditions

• Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria

Interventions

Type	Name	Description
DRUG	TQD3606	TQD3606 is a fixed-dose combination of meropenem and avibactam. Meropenem is a carbapenem antimicrobial agent, and avibactam is a β-lactamase inhibitor.

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-05-06
• Completion: 2025-05-06
• First posted: 2024-11-04
• Last updated: 2026-01-09

Locations

2 sites across 1 country: China