Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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 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 RPX7009, administered alone, in healthy adult subjects.

Conditions

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Healthy Volunteers Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ascending Single and Multiple dose of RPX7009

Group Type EXPERIMENTAL

RPX7009

Intervention Type DRUG

Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Normal Saline

Ascending Single and multiple dose of normal saline.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Interventions

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RPX7009

Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Intervention Type DRUG

Placebo

Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Intervention Type DRUG

Other Intervention Names

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(beta-lactamase inhibitor) Normal saline

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age
* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
* Medically healthy with clinically insignificant screening results
* Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
* Sexually abstinent or use acceptable methods of birth control

Exclusion Criteria

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
* Documented hypersensitivity reaction or anaphylaxis to any medication.
* Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
* Plasma donation within 7 days prior to Day 1.
* Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes