Condition or disease | Intervention/treatment | Phase |
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Bacterial Infections | Drug: QPX2015 Drug: Placebo oral capsule | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | double-blind, placebo controlled ascending single- and multiple-dose |
Masking: | Double (Participant, Investigator) |
Masking Description: | double-blind, placebo controlled ascending single- and multiple-dose |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Oral QPX2015 in Healthy Adult Subjects |
Actual Study Start Date : | May 20, 2019 |
Actual Primary Completion Date : | October 6, 2019 |
Actual Study Completion Date : | October 6, 2019 |
Arm | Intervention/treatment |
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Experimental: QPX2015
QPX2015, antibiotic
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Drug: QPX2015
antibiotic
Other Name: oral dose
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Placebo Comparator: Placebo
Matched placebo
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Drug: Placebo oral capsule
Placebo comparator
Other Name: oral dose
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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Australia, South Australia | |
CMAX | |
Adelaide, South Australia, Australia |
Study Director: | Jeffery S Loutit, MBChB | Qpex Biopharma, Inc. |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 1, 2019 | ||||||
First Posted Date ICMJE | May 6, 2019 | ||||||
Last Update Posted Date | October 23, 2019 | ||||||
Actual Study Start Date ICMJE | May 20, 2019 | ||||||
Actual Primary Completion Date | October 6, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects | ||||||
Official Title ICMJE | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Oral QPX2015 in Healthy Adult Subjects | ||||||
Brief Summary | 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. | ||||||
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 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: double-blind, placebo controlled ascending single- and multiple-dose Masking: Double (Participant, Investigator)Masking Description: double-blind, placebo controlled ascending single- and multiple-dose Primary Purpose: Treatment
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Condition ICMJE | Bacterial Infections | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE |
50 | ||||||
Actual Study Completion Date ICMJE | October 6, 2019 | ||||||
Actual Primary Completion Date | October 6, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03939429 | ||||||
Other Study ID Numbers ICMJE | Qpex-100 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Qpex Biopharma, Inc. | ||||||
Study Sponsor ICMJE | Qpex Biopharma, Inc. | ||||||
Collaborators ICMJE | Biomedical Advanced Research and Development Authority | ||||||
Investigators ICMJE |
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PRS Account | Qpex Biopharma, Inc. | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |