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NCT04808414 · ClinicalTrials.gov registry record · Phase 1
SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers
A Phase 1 study, sponsored by Qpex Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
NCT04808414 is a Phase 1 study that has completed, run by Qpex Biopharma. The registered enrollment target is 104 participants.
The verdict
NCT04808414, a Phase 1 study, has completed, sponsored by Qpex Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
Study 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. In particular, the presence of multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in hospitals around the world poses a considerable threat. .
Interventions
- DRUG QPX9003 for IV Infusion
- DRUG Placebo for IV infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2021-06-03 |
| Est. Completion | 2022-07-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04808414
The ClinicalTrials.gov registry entry for NCT04808414 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Qpex Biopharma, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which QPX9003 for IV Infusion is the first listed.
NCT04808414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04808414 about?
NCT04808414 is a clinical study titled "SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers". 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 Pseudomona...
What is the current status of trial NCT04808414?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2021-06-03. Estimated completion is 2022-07-14.
What interventions are being tested in trial NCT04808414?
The interventions under investigation include: QPX9003 for IV Infusion (DRUG), Placebo for IV infusion (DRUG).
Who is sponsoring clinical trial NCT04808414?
This trial is sponsored by Qpex Biopharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
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