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Beta-lactamase Inhibitor
QPX7831 for Bacterial Infection
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 17 days
Awards & highlights
Study Summary
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 17 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 17 days
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
Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses)
Number of patients with changes from baseline in safety parameters
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: QPX7831 SAD CohortsExperimental Treatment2 Interventions
oral, single ascending dose (or placebo)
Group II: QPX7831 MAD CohortsExperimental Treatment2 Interventions
oral, multiple ascending dose (or placebo)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QPX7831
2021
Completed Phase 1
~80
placebo comparator
2016
Completed Phase 4
~4390
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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
342 Total Patients Enrolled
Biomedical Advanced Research and Development AuthorityFED
79 Previous Clinical Trials
909,223 Total Patients Enrolled
Jeffery Loutit, MBChBStudy DirectorQpex Biopharma, Inc.
Frequently Asked Questions
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