AzTrials
AzTrials

Bacterial InfectionsPhase 1NCT04380207

P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV

A Phase 1 study testing QPX7728 and QPX2014 in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bacterial Infections
What is being tested?
QPX7728 and QPX2014
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
2 sitesin 2 countries
Study dates
24 Nov 2020to 31 Aug 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult males and/or females of non-child bearing potential, 18 to 55 years of age (inclusive).
  • 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 (e.g., laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination) as assessed by the PI.
  • Voluntarily consent to participate in the study.
  • 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.
  • Females of non-childbearing potential with serum follicle stimulating hormone (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.

Who cannot join

  • History or presence of significant (based on the PI assessment) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • Positive urine drug/alcohol testing at screening or check-in (Day -1). A repeat test may be performed at the Investigator's discretion in circumstances where a positive result is suspected to be caused by consumption of non-illicit substances.
  • Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
  • History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
  • Use of more than an average of 5 packs/week of tobacco/nicotine-containing product within 6 months prior to Day 1. Subjects must agree to refrain from smoking for the duration of the study.
  • Excessive intake of alcohol, defined as an average daily intake of greater than 2 standard drinks for women and 4 standard drinks for men, (1 bottle of beer (375mL) is equivalent to approximately 1.4 standard drinks, 1 glass of spirits (30mL) is equivalent to approximately 1 standard drink and 1 glass (150mL) of wine is equivalent to approximately 1.5 standard drinks).
Show all 22Show fewer
  • Use of any prescription medication (with the exception of hormone replacement therapy for females) within 14 days prior to Day 1.
  • Use of any over-the-counter (OTC) medication, including herbal products, probiotics and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of paracetamol is allowed for acute events at the discretion of the PI.
  • Use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to Day 1.
  • Documented hypersensitivity reaction or anaphylaxis to any medication, including beta-lactam antibiotics.
  • Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
  • Plasma donation within 7 days prior to Day 1.
  • Participation in another investigational clinical trial within 30 days prior to Day 1 or within 5 half-lives of the previous investigational drug, whichever is longer.
  • Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant.
  • Any significant (based on the PI assessment) acute illness within 30 days prior to Day 1.
  • QTcF interval >450 msec for males and >470 for females or history of prolonged QT syndrome at screening or check-in (Day -1).
  • Calculated creatinine clearance less than 80 mL/min (Cockcroft- Gault method) at screening or check-in (Day -1).
  • Subjects who have any clinically significant abnormalities on laboratory values at screening or check-in (Day -1), in particular:
  • White blood cell count < 3,000/mm3, hemoglobin < 11g/dL.
  • Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3.
  • Liver function abnormalities at screening or check-in (Day -1) (defined by an elevation in bilirubin, AST or ALT > ULN of the normal range for subjects based on age and sex).
  • Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Altasciences

    Cypress, California, 90630

Other trials in United States

Australia1 site

  • CMAX

    Adelaide, South Australia

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of Intravenous (IV) QPX7728 Alone and in Combination With QPX2014 in Healthy Adult Subjects

QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P. aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes, such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-beta-lactamase (VIM), and class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.

Read the detailed description

The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae as serious threats [CDC, 2019]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant, ESBL-producing Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii, and carbapenem-resistant Pseudomonas aeruginosa as pathogens for which new agents are critically needed [WHO, 2017].

Qpex Biopharma is developing a fixed combination antibiotic of QPX2014 plus an ultra-broad spectrum beta-lactamase inhibitor, QPX7728.

Being tested
QPX7728, Placebo, QPX2014
Keywords
beta-lactam antibiotic
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QPX7728Drug

    Also called IV

    antibiotic

  • PlaceboDrug

    Also called IV saline

    Placebo comparator

  • QPX2014Drug

    Also called IV

    antibiotic

Study groups in NCT04380207
Study groupRoleWhat they receive
QPX7728Experimentalantibiotic
Receives: Drug: QPX7728
PlaceboPlacebo comparatorMatched placebo
Receives: Drug: Placebo
QPX2014Experimentalantibiotic
Receives: Drug: QPX2014

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment -Emergent Adverse events (AEs) by subject and by cohort (single, multiple and combination dose)

    Number of patients with Treatment-Emergent AEs by treatment arm, severity and relationship to treatment

    Measured: up to 21 days

  2. Number of patients with changes from baseline in safety parameters (single, multiple and combination dose)

    Number of patients with changes in safety parameters before and after dosing by subject and treatment arm

    Measured: up to 21 days

  3. Peak plasma Concentration measurements by subject and by cohort (Cmax) (single, multiple and combination dose)

    Comparison will be performed between the cohorts for Cmax. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.

    Measured: up to 21 days

  4. Area under the plasma concentration versus time curve (AUC) between cohorts (single, multiple and combination dose)

    Comparison will be performed between the cohorts for AUC. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.

    Measured: up to 21 days

  5. Urine Pharmacokinetic (PK) amount excreted by subject and by cohort (single, multiple and combination dose)

    Urine PK parameters such as amount excreted will be calculated from urinary excretion data

    Measured: up to 21 days

  6. Urine PK % dose excreted by subject and by cohort (single, multiple and combination dose)

    Urine PK parameters such as amount of % dose excreted will be calculated from urinary excretion data

    Measured: up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start24 Nov 2020
  3. Primary completion31 Aug 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double-blind, placebo controlled ascending single, multiple and combination dose
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380207
Sponsor's protocol ID
Qpex-200
Status last verified
Sep 2022
First submitted
21 Apr 2020
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing QPX7728 and QPX2014 in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment -Emergent Adverse events (AEs) by subject and by cohort (single, multiple and combination dose) (time frame: up to 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04380207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in