Completed

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 in Healthy Adult Subjects

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What is being tested

RPX2003 (Biapenem)

+ Placebo

Drug
Who is being recruted

Bacterial Infections and Mycoses

+ Infections

+ Bacterial Infections

From 18 to 55 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorRempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Last updated: December 3, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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 recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents. Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2003 or biapenem) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of biapenem, administered alone, in healthy adult subjects.

NCT01702649
Principal SponsorRempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Last updated: December 3, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesInfectionsBacterial Infections

Criteria

5 inclusion criteria required to participate
Body mass index (BMI) >= 18.5 and <= 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
Healthy adult males and/or females, 18 to 55 years of age
Medically healthy with clinically insignificant screening results
Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1
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7 exclusion criteria prevent from participating
Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1
History of seizures (e.g., epilepsy)
History or presence of alcoholism or drug abuse within the 2 years prior to Day 1
History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Single and multiple dose of RPX2003 (Biapenem).

Group II

Placebo
Single and multiple doses of normal saline.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Celerion

Tempe, United StatesOpen Celerion in Google Maps
CompletedOne Study Center