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SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers

NCT04808414 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-10-10

No results posted yet for this study

Summary

The worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the presence of multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in hospitals around the world poses a considerable threat.

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Conditions

Interventions

DRUG

QPX9003 for IV Infusion

antibiotic

DRUG

Placebo for IV infusion

Placebo comparator

Sponsors & Collaborators

Principal Investigators

  • Jeffery S Loutit, MBChB · Qpex Biopharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2022-07-14
Completion
2022-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04808414 on ClinicalTrials.gov