Bacterial InfectionsPhase 1QPX9003NCT04808414
SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers
A Phase 1 study testing QPX9003 for IV Infusion in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- QPX9003 for IV Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 14 Jul 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 60 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 60 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 a condom when engaging in any sexual activity from Day -1 check-in to the clinic 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:
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- 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.
- Barrier method (diaphragm) for at least 14 days prior to Day 1 through 30 days following the final dosing of the study drug.
- Stable hormonal contraceptive for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug.
- Surgical sterilization (vasectomy) at least 6 months prior to Day 1.
- Females of non-childbearing potential must meet at least one of the following criteria:
- postmenopausal (defined as 12 months spontaneous amenorrhea) with a serum FSH leve l≥ 40 mIU/mL.
- have undergone one of the following sterilization procedures documented at least 6 months prior to Day 1:
- Bilateral tubal ligation
- Hysterectomy
- Hysterectomy with unilateral or bilateral oophorectomy
- Bilateral oophorectomy
- Females who practice true abstinence or are in same sex relationships where there is no possibility of conception.
- In addition to meeting Inclusion Criteria 1 through 6, cCohort 12 will consist of normal healthy Chinese subjects who are either:
- First generation Chinese subjects born in China, with 2 Chinese biological parents and 4 Chinese grandparents born in China of full Chinese descent.
- Subject has lived less than or equal to 10 years outside of China. ii. In addition to mainland China, subjects or their parents and grandparents may also be from Taiwan, Hong Kong, or Mongolia, or b. Second generation Chinese subjects born outside of China with 2 Chinese biological parents and 4 grandparents born in China of full Chinese descent.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug screen or alcohol breath test at screening or check-in (Day -1).
- Positive testing for HIV, hepatitis B or C
- History or presence of alcoholism or drug abuse within last 2 years
- Use of more than 5 packs/week of tobacco/nicotine-containing product within last 6 months prior dosing.
- Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to dosing.
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- Use of any over-the-counter (OTC) medication, including herbal products, probiotics and vitamins, within the 7 days prior to dosing.
- Use of antacids, H2 receptor blockers or proton pump inhibitors 7 days prior to dosing.
- History of any hypersensitivity reaction or anaphylaxis to any medication, including polymyxin antibiotics.
- 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.
- QTcF interval >450 msec for males and >470 msec for females, or history of prolonged QT syndrome at screening or check-in.
- Calculated creatinine clearance less than 80 mL/min (Cockcroft-Gault method) at screening or check-in.
- 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.
- Liver function abnormalities defined by an elevation in bilirubin, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) 1.5 x Upper Limit of Normal (ULN) of the normal range for subjects based on age and sex.
Trial locations and contacts
1 site in 1 country.
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) QPX9003 in Healthy Adult Subjects
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 presence of multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in hospitals around the world poses a considerable threat.
.
Read the detailed description
The United States (US) Centers for Disease Control (CDC) have listed multidrug-resistant (MDR) Acinetobacter and MDR Pseudomonas aeruginosa as serious threats [CDC, 2019]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant Acinetobacter baumannii, and carbapenem resistant Pseudomonas aeruginosa as critical threats [WHO, 2017].
To combat these serious threats Qpex has developed QPX9003, a next generation polymyxin that is more potent than existing polymyxins against P. aeruginosa and A. baumannii and has exhibited less nephrotoxicity in preclinical studies.
There remains a significant unmet need for new IV agents to treat gram-negative infections due to resistant bacteria in hospital settings. Some progress has been made in the successful development of new agents to address drug-resistant infections, particularly IV agents for resistant gram-negative bacteria [Talbot et al, 2019]. While some of these agents have addressed urgent threats like carbapenem-resistant Enterobacteriaceae (CRE), their activity is largely confined to strains producing serine carbapenemases; none of these agents have reliable activity against metallo beta-lactamase producing CRE. Moreover, none of these recently approved agents have activity against carbapenem-resistant Acinetobacter baumannii [Talbot et al, 2019]. The increasing prevalence of multidrug-resistant gram-negative bacteria, in particular carbapenemase producing Enterobacteriaceae, A. baumannii, and P. aeruginosa, has resulted in an increase in the use of polymyxin antibiotics as salvage therapy [Biswas et al. 2017].
This Phase 1 study will assess the safety, tolerability and pharmacokinetics of single and multiple IV administered ascending doses (SAD/MAD) of IV QPX9003 in healthy adult subjects.
Qpex is developing IV QPX9003 which is a next generation polymyxin with activity against multi-drug resistant A. baumannii and P. aeruginosa
- Conditions
- Bacterial Infections
- Being tested
- QPX9003 for IV Infusion, Placebo for IV infusion
- Keywords
- polymyxin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QPX9003 for IV InfusionDrug
Also called novel IV polymyxin antibiotic
antibiotic
Placebo for IV infusionDrug
Also called IV saline
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| QPX9003 for IV infusion | Experimental | IV novel polymyxin antibiotic Single and Multiple IV doses x 7 days via IV infusion q6hrs Receives: Drug: QPX9003 for IV Infusion |
| Placebo for Infusion | Placebo comparator | IV saline Single and Multiple IV doses x 7 days via IV infusion q6hrs Receives: Drug: Placebo for IV infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 13 days
Peak plasma Concentration measurements by subject and by cohort (Cmax) (single 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 13 days
Area under the plasma concentration versus time curve (AUC) between cohorts (single and multiple 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 13 days
Urine amount excreted by subject and by cohort (single and combination dose)-PK
Urine amount excreted will be calculated from urinary excretion data
Measured: up to 13 days
Urine % dose excreted by subject and by cohort (single and multiple dose)-PK
Urine amount of % dose excreted will be calculated from urinary excretion data
Measured: up to 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start3 Jun 2021
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- double-blind, placebo controlled ascending single and multiple dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 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 S Loutit, MBChB, Study director, Qpex Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808414
- Sponsor's protocol ID
- Qpex-300
- Acronym
- QPX9003
- Status last verified
- Jul 2022
- First submitted
- 16 Mar 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watkins M, Zhu Y, Griffith DC, Loutit JS, Margolis D, Gu P. Phase 1 study of the safety, tolerability, and pharmacokinetics of a synthetic macrocyclic peptide antibiotic (BRII-693) in healthy adult participants. Antimicrob Agents Chemother. 2025 Jan 31;69(1):e0128824. doi: 10.1128/aac.01288-24. Epub 2024 Dec 9.
PubMed 39651882
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 Intravenous (IV) QPX9003 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04808414
- Acronym / sponsor ID
- QPX9003 / Qpex-300
- Conditions
- Bacterial Infections
- Keywords
- polymyxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Qpex Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 22 Mar 2021 (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.
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 presence of multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in hospitals around the world poses a considerable threat.
.
Detailed description
The United States (US) Centers for Disease Control (CDC) have listed multidrug-resistant (MDR) Acinetobacter and MDR Pseudomonas aeruginosa as serious threats [CDC, 2019]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant Acinetobacter baumannii, and carbapenem resistant Pseudomonas aeruginosa as critical threats [WHO, 2017].
To combat these serious threats Qpex has developed QPX9003, a next generation polymyxin that is more potent than existing polymyxins against P. aeruginosa and A. baumannii and has exhibited less nephrotoxicity in preclinical studies.
There remains a significant unmet need for new IV agents to treat gram-negative infections due to resistant bacteria in hospital settings. Some progress has been made in the successful development of new agents to address drug-resistant infections, particularly IV agents for resistant gram-negative bacteria [Talbot et al, 2019]. While some of these agents have addressed urgent threats like carbapenem-resistant Enterobacteriaceae (CRE), their activity is largely confined to strains producing serine carbapenemases; none of these agents have reliable activity against metallo beta-lactamase producing CRE. Moreover, none of these recently approved agents have activity against carbapenem-resistant Acinetobacter baumannii [Talbot et al, 2019]. The increasing prevalence of multidrug-resistant gram-negative bacteria, in particular carbapenemase producing Enterobacteriaceae, A. baumannii, and P. aeruginosa, has resulted in an increase in the use of polymyxin antibiotics as salvage therapy [Biswas et al. 2017].
This Phase 1 study will assess the safety, tolerability and pharmacokinetics of single and multiple IV administered ascending doses (SAD/MAD) of IV QPX9003 in healthy adult subjects.
Qpex is developing IV QPX9003 which is a next generation polymyxin with activity against multi-drug resistant A. baumannii and P. aeruginosa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blind, placebo controlled ascending single and multiple dose
| Arm | Type | Receives |
|---|---|---|
| QPX9003 for IV infusion | Experimental | Drug: QPX9003 for IV InfusionIV novel polymyxin antibiotic Single and Multiple IV doses x 7 days via IV infusion q6hrs |
| Placebo for Infusion | Placebo comparator | Drug: Placebo for IV infusionIV saline Single and Multiple IV doses x 7 days via IV infusion q6hrs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Healthy adult males and/or females of non-child bearing potential, 18 to 60 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 a condom when engaging in any sexual activity from Day -1 check-in to the clinic 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.
Key exclusion criteria (15 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug screen or alcohol breath test at screening or check-in (Day -1).
- Positive testing for HIV, hepatitis B or C
- History or presence of alcoholism or drug abuse within last 2 years
- Use of more than 5 packs/week of tobacco/nicotine-containing product within last 6 months prior dosing.
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 |
|---|---|---|
| QPX9003 for IV InfusionAlso: novel IV polymyxin antibioticantibiotic | Drug | QPX9003 for IV infusion |
| Placebo for IV infusionAlso: IV salinePlacebo comparator | Drug | Placebo for Infusion |
Primary outcome
Incidence of Treatment -Emergent Adverse events (AEs) by subject and by cohort (single, multiple and combination dose)
Time frame: up to 21 days
Number of patients with Treatment-Emergent AEs by treatment arm, severity and relationship to treatment
Number of patients with changes from baseline in safety parameters (single, multiple and combination dose)
Time frame: up to 13 days
Number of patients with changes in safety parameters before and after dosing by subject and treatment arm
Peak plasma Concentration measurements by subject and by cohort (Cmax) (single and combination dose)
Time frame: up to 13 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.
Area under the plasma concentration versus time curve (AUC) between cohorts (single and multiple dose)
Time frame: up to 13 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 amount excreted by subject and by cohort (single and combination dose)-PK
Time frame: up to 13 days
Urine amount excreted will be calculated from urinary excretion data
Urine % dose excreted by subject and by cohort (single and multiple dose)-PK
Time frame: up to 13 days
Urine 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.
- Derived from this study: PubMed 39651882Watkins M, Zhu Y, Griffith DC, Loutit JS, Margolis D, Gu P. Phase 1 study of the safety, tolerability, and pharmacokinetics of a synthetic macrocyclic peptide antibiotic (BRII-693) in healthy adult participants. Antimicrob Agents Chemother. 2025 Jan 31;69(1):e0128824. doi: 10.1128/aac.01288-24. Epub 2024 Dec 9.
- 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 S Loutit, MBChB study director
Qpex Biopharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QPX9003 for IV Infusion in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in United States.
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 21 inclusion and 15 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 1 site in United States. 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 NCT04808414, which also lists 1 linked publication.
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.