Phase 1 Study of Oral QPX2015 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2019-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

QPX2015 (beta-lactam antibiotic) is being studied at higher than approved doses to combine with a new beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01751269

Healthy Volunteers Bacterial Infections

COMPLETED PHASE1

Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects

NCT01897779

Healthy Volunteers Bacterial Infections

COMPLETED PHASE1

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

NCT01702649

Healthy Volunteers Bacterial Infections

COMPLETED PHASE1

Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination

NCT01772836

Healthy Volunteers Bacterial Infections

COMPLETED PHASE1

Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects

NCT02073812

Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 both hospital acquired and community acquired infections. In particular, the increase in Enterobacteriaceae expressing extended spectrum beta-lactamases (ESBLs) and carbapenemases that are resistant to all oral beta-lactams and fluoroquinolones in the community have resulted in many patients requiring admission just for IV antibiotics to treat their infections.

Qpex Biopharma is developing a fixed combination antibiotic of QPX2015 (beta-lactam antibiotic) plus a new beta-lactamase inhibitor.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind, placebo controlled ascending single- and multiple-dose

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind, placebo controlled ascending single- and multiple-dose

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

QPX2015

QPX2015, antibiotic

Group Type EXPERIMENTAL

QPX2015

Intervention Type DRUG

antibiotic

Placebo

Matched placebo

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QPX2015

antibiotic

Intervention Type DRUG

Placebo oral capsule

Placebo comparator

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oral dose oral dose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy adult males and/or females of non-child bearing potential, 18 to 55 years of age (inclusive).
2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms \[ECGs\], physical examination) as assessed by the PI.
4. Voluntarily consent to participate in the study.
5. If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from study check-in through completion of the end-of-study. Subjects must agree to use two approved methods of contraception for 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
6. Females of non-childbearing potential with serum FSH levels ≥ 40 mIU/mL are either postmenopausal (defined as 12 months spontaneous amenorrhea) or have undergone sterilization procedures at least 6 months prior to dosing.

Exclusion Criteria

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
2. Positive urine drug/alcohol testing at screening or check-in (Day -1).
3. Positive testing for HIV, hepatitis B or C
4. History or presence of alcoholism or drug abuse within last 2 years
5. Use of more than 5 packs/week of tobacco/nicotine-containing product within last 6 months prior dosing.
6. Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to dosing.
7. Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to dosing.
8. Use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to dosing.
9. History of any hypersensitivity or allergic reaction to cephalosporins, penicillins, carbapenems, or monobactams).
10. Participation in another investigational clinical trial within 30 days prior to Dosing or within 5 half-lives of the previous investigational drug, whichever is longer.
11. Females who are pregnant or lactating.
12. QTcF interval \>450 msec, or history of prolonged QT syndrome at screening or check-in
13. Calculated creatinine clearance less than 80 mL/min (Cockcroft-Gault method) at screening or check-in.
14. Subjects who have any clinically significant abnormalities on laboratory values: White blood cell count \< 3,000/mm3, hemoglobin \< 11g/dL or Absolute neutrophil count \< 1,200/mm3 or platelet count \< 120,000/mm3.
15. Liver function abnormalities defined by an elevation in bilirubin, AST or ALT 1.5 x ULN of the normal range for subjects based on age and sex.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes