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Antibiotic

Xeruborbactam + Cefiderocol for Bacterial Infections

Phase 1

Recruiting

Research Sponsored by Qpex Biopharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, 18 to 55 years of age at the time of signing the informed consent

Be between 18 and 65 years old

Must not have

History of any severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or any other beta-lactam antibacterial drugs, or any other excipients used in the formulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)

Females who are pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 17 days

Summary

This trial will test the safety and how well cefiderocol works when combined with xeruborbactam in healthy adults.

Who is the study for?

This trial is for healthy adults who can participate in a study to understand how two drugs interact with each other. Specific eligibility details are not provided, but typically participants should have no significant health issues.

What is being tested?

The study tests the interaction between Xeruborbactam and Cefiderocol, both antibiotics, in healthy adults. It's randomized and placebo-controlled, meaning some people get the real drugs while others get an inactive substance without knowing which one they received.

What are the potential side effects?

Since this is a phase 1 trial primarily focused on safety and how the body processes the drugs (pharmacokinetics), potential side effects may include typical drug reactions such as nausea, headaches, allergic reactions or site-specific issues like pain where the drug was administered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain antibiotics like penicillins or cephalosporins.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 17 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~17 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 17 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the plasma concentration versus time curve (AUC) between cohorts

Number of patients with changes from baseline in safety parameters

Peak plasma Concentration measurements by subject and by cohort (Cmax)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Single Dose CohortsExperimental Treatment3 Interventions

Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.

Group II: Single Dose Cohorts PlaceboPlacebo Group1 Intervention

5% Dextrose in water

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cefiderocol

2020

Completed Phase 4

~1900

0 / 3Eligibility criteria met