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Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

NCT01702649 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-12-03

No results posted yet for this study

Summary

RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

Conditions

Interventions

DRUG

RPX2003 (Biapenem)

Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation. Single dose followed by multiple dose, three times a day.

DRUG

Placebo

Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation. Single dose followed by multiple dose, three times a day.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Jeff 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
2012-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01702649 on ClinicalTrials.gov