NCT05340530

To Evaluate the Pharmacokinetic Effects of TQD3606 for Injection in Healthy Adult Subjects

Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Injectable TQD3606 in a Single Center, Randomized, Double-blind, Placebo-controlled, Single, Multiple Dosing in Healthy Subjects, and to Explore Urinary Excretion of the Product

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

TQD3606 is a fixed-dose combination of meropenem and avibatam. This study is a phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQD3606 injection in a single center, randomized, double-blind, placebo-controlled, single and multiple administration in healthy subjects, and to explore the excretion of TQD3606 in urine. To evaluate the tolerability and safety of injectable TQD3606 after single and multiple dosing in healthy subjects.

Conditions

• Infections

Interventions

Type	Name	Description
DRUG	The injectable TQD3606	TQD3606 is a fixed-dose combination of meropenem and avibatam.
DRUG	meropenem	Meropenem is a carbapenem antibiotic
DRUG	Avibactam Sodium	Avibactam is beta-lactamase inhibitor.
DRUG	Placebo	It is a placebo.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-04-22
• Last updated: 2022-04-22

Locations

1 site across 1 country: China