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Polymyxin

QPX9003 for IV Infusion for Bacterial Infection (QPX9003 Trial)

Phase 1
Waitlist Available
Research Sponsored by Qpex Biopharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights

QPX9003 Trial Summary

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

QPX9003 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration versus time curve (AUC) between cohorts (single and multiple dose)
Incidence of Treatment -Emergent Adverse events (AEs) by subject and by cohort (single, multiple and combination dose)
Number of patients with changes from baseline in safety parameters (single, multiple and combination dose)
+3 more

QPX9003 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: QPX9003 for IV infusionExperimental Treatment1 Intervention
IV novel polymyxin antibiotic Single and Multiple IV doses x 7 days via IV infusion q6hrs
Group II: Placebo for InfusionPlacebo Group1 Intervention
IV saline Single and Multiple IV doses x 7 days via IV infusion q6hrs
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QPX9003 for IV Infusion
2021
Completed Phase 1
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Qpex Biopharma, Inc.Lead Sponsor
6 Previous Clinical Trials
313 Total Patients Enrolled
Biomedical Advanced Research and Development AuthorityFED
80 Previous Clinical Trials
909,291 Total Patients Enrolled
Jeffery S Loutit, MBChBStudy DirectorQpex Biopharma, Inc.
2 Previous Clinical Trials
122 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers
2021. "SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04808414.
~27 spots leftby Apr 2025
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