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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01751269

Enrollment

Registered

2012-12-17

Start date

2012-12-31

Completion date

2013-07-31

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections, Healthy Volunteers

Brief 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.

Detailed description

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.

Interventions

DRUGRPX7009

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Safety from baseline through the end of the study.	Study Day 1 to Day 13.	Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

Secondary

Measure	Time frame	Description
Composite of PK parameters RPX7009 & placebo following single dose administration.	Study Day 1 to Day 12	Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026