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Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination

NCT01772836 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-07-11

No results posted yet for this study

Summary

RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

Conditions

Interventions

DRUG

RPX7009

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

DRUG

Biapenem

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

DRUG

Normal saline

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Sponsors & Collaborators

  • Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

    lead INDUSTRY

Principal Investigators

  • Jefferey Loutit, MBChB · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

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 NCT01772836 on ClinicalTrials.gov