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

NCT05340530 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-04-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05340530 on ClinicalTrials.gov