Bacterial InfectionsPhase 1NCT04578873
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
A Phase 1 study testing QPX7831 in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 2 sites in 2 countries.
Trial summary
This Phase 1 study will assess the safety, tolerability, and pharmacokinetics (PK) of QPX7831, a beta-lactamase inhibitor, when administered orally in single ascending doses and in multiple ascending doses to heathy adult subjects. 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?
- QPX7831
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Apr 2021to 30 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-childbearing potential, 18 to 55 years of age (inclusive) at the time of screening.
- 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.
- Male volunteers must agree to use a condom when engaging in any sexual activity from study check-in through 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. If engaging in sexual activity with a female partner of childbearing potential, an additional method of birth control must be used. Approved additional methods of birth control include:
- Intra-uterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug.
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- Barrier method (diaphragm) for at least 14 days prior to Day 1 through 30 days following dosing of the study drug.
- Stable hormonal contraceptive for at least 3 months prior to Day 1 through 30 days following dosing of the study drug.
- Surgical sterilization (vasectomy) at least 6 months prior to Day 1.
- Females of non-childbearing potential with serum FSH levels ≥ 40 mIU/mL are either postmenopausal (defined as 12 months spontaneous amenorrhea) or have undergone one of the following sterilization procedures at least 6 months prior to Day 1 (and is documented):
- Bilateral tubal ligation;
- Hysterectomy;
- Hysterectomy with unilateral or bilateral oophorectomy;
- Bilateral oophorectomy.
Who cannot join
- History or presence of significant 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).
- 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 5 packs/week of cigarettes (or equivalent amount of 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.
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- 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 within 7 days prior to Day 1.
- Documented hypersensitivity reaction or anaphylaxis to any medication
- Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day
- 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.
- Females who are pregnant or lactating.
- Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant.
- Any 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 1.5 x 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
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 Oral QPX7831 in Healthy Adult Subjects
This Phase 1 study will assess the safety, tolerability, and pharmacokinetics (PK) of QPX7831, a beta-lactamase inhibitor, when administered orally in single ascending doses and in multiple ascending doses to heathy adult subjects.
Read the detailed description
Qpex Biopharma, Inc. is developing an oral dosage form that delivers QPX7728, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic.
The objectives are:
- To assess the safety and tolerability of QPX7831 when administered orally in single ascending doses (SAD) and in multiple ascending doses (MAD) to healthy adult subjects.
- To assess the PK of single and multiple doses of oral QPX7831 when administered to healthy adult subjects to determine if the target exposures identified in preclinical studies can be attained in healthy adult subjects.
- Conditions
- Bacterial Infections
- Being tested
- QPX7831, placebo comparator
- Keywords
- beta-lactamase inhibitor
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QPX7831Drug
capsule
placebo comparatorDrug
oral matched placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| QPX7831 SAD Cohorts | Experimental | oral, single ascending dose (or placebo) Receives: Drug: QPX7831; Drug: placebo comparator |
| QPX7831 MAD Cohorts | Experimental | oral, multiple ascending dose (or placebo) Receives: Drug: QPX7831; Drug: placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses)
Number of patients with Treatment-Emergent AEs by subject, by cohort, severity and relationship to treatment
Measured: up to 17 days
Number of patients with changes from baseline in safety parameters
Number of patients with changes in safety parameters before and after dosing by subject and cohort
Measured: up to 17 days
Peak plasma Concentration measurements by subject and by cohort (Cmax)
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 17 days
Time concentration data measurements by subject and by cohort (Tmax)
Comparison will be performed between the cohorts for Tmax.
Measured: up to 17 days
Area under the plasma concentration versus time curve (AUC) between cohorts
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 17 days
Urine PK amount excreted by subject and by cohort
Urine PK parameters such as amount excreted will be calculated from urinary excretion data
Measured: up to 17 days
Urine PK % dose excreted by subject and by cohort
Urine PK parameters such as amount of % dose excreted will be calculated from urinary excretion data
Measured: up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start13 Apr 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Model description
- Double-blind, placebo-controlled, sequential, ascending single-and multiple-dose design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qpex Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Jeffery Loutit, MBChB, Study director, Qpex Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578873
- Sponsor's protocol ID
- Qpex-101
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Oral QPX7831 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04578873
- Acronym / sponsor ID
- Qpex-101
- Conditions
- Bacterial Infections
- Keywords
- beta-lactamase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Qpex Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study will assess the safety, tolerability, and pharmacokinetics (PK) of QPX7831, a beta-lactamase inhibitor, when administered orally in single ascending doses and in multiple ascending doses to heathy adult subjects.
Detailed description
Qpex Biopharma, Inc. is developing an oral dosage form that delivers QPX7728, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic.
The objectives are:
- To assess the safety and tolerability of QPX7831 when administered orally in single ascending doses (SAD) and in multiple ascending doses (MAD) to healthy adult subjects.
- To assess the PK of single and multiple doses of oral QPX7831 when administered to healthy adult subjects to determine if the target exposures identified in preclinical studies can be attained in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, sequential, ascending single-and multiple-dose design
| Arm | Type | Receives |
|---|---|---|
| QPX7831 SAD Cohorts | Experimental | Drug: QPX7831, Drug: placebo comparatororal, single ascending dose (or placebo) |
| QPX7831 MAD Cohorts | Experimental | Drug: QPX7831, Drug: placebo comparatororal, multiple ascending dose (or placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive) at the time of screening.
- 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.
- Male volunteers must agree to use a condom when engaging in any sexual activity from study check-in through 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. If engaging in sexual activity with a female partner of childbearing potential, an additional method of birth control must be used. Approved additional methods of birth control include:
Key exclusion criteria (23 listed)
- History or presence of significant 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).
- 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 5 packs/week of cigarettes (or equivalent amount of nicotine-containing product) within 6 months prior to Day 1. Subjects must agree to refrain from smoking for the duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QPX7831capsule | Drug | QPX7831 MAD Cohorts, QPX7831 SAD Cohorts |
| placebo comparatororal matched placebo capsule | Drug | QPX7831 MAD Cohorts, QPX7831 SAD Cohorts |
Primary outcome
Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses)
Time frame: up to 17 days
Number of patients with Treatment-Emergent AEs by subject, by cohort, severity and relationship to treatment
Number of patients with changes from baseline in safety parameters
Time frame: up to 17 days
Number of patients with changes in safety parameters before and after dosing by subject and cohort
Peak plasma Concentration measurements by subject and by cohort (Cmax)
Time frame: up to 17 days
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.
Time concentration data measurements by subject and by cohort (Tmax)
Time frame: up to 17 days
Comparison will be performed between the cohorts for Tmax.
Area under the plasma concentration versus time curve (AUC) between cohorts
Time frame: up to 17 days
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.
Urine PK amount excreted by subject and by cohort
Time frame: up to 17 days
Urine PK parameters such as amount excreted will be calculated from urinary excretion data
Urine PK % dose excreted by subject and by cohort
Time frame: up to 17 days
Urine PK parameters such as amount of % dose excreted will be calculated from urinary excretion data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Loutit, MBChB study director
Qpex Biopharma, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QPX7831 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 14 inclusion and 23 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. 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 by subject and by cohort (single dose, multiple doses) (time frame: up to 17 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.