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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Safety from baseline through the end of the study.
Study Overview
Brief 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.
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 (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy adult males and/or females, 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
- •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
- •Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
- •History of seizures (e.g., epilepsy).
- •Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day
- •Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
- •Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day
- •Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Arms & Interventions
RPX2003 (Biapenem)
Single and multiple dose of RPX2003 (Biapenem).
Intervention: RPX2003 (Biapenem) (Drug)
Normal Saline
Single and multiple doses of normal saline.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety from baseline through the end of the study.
Time Frame: Study Day 1 to 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 Outcomes
- Composite of PK parameters RPX2003 & placebo following single dose administration.(Part 1A Study Day 1 to 3.)
- Composite of PK parameters RPX2003 & placebo following multiple dose administration.(Part 1B Day 4 to 12)