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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: Completed Phase 1 study, sponsored by Qpex Biopharma.
NCT04808414 is a Phase 1 study that has completed, run by Qpex Biopharma. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
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. .
Primary Outcome
Number of patients with Treatment-Emergent AEs by treatment arm, severity and relationship to treatment
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 |
What the finished NCT04808414 record still lists
NCT04808414 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher).
The record links to 0 conditions, and to 2 interventions - of which QPX9003 for IV Infusion is the first listed.
NCT04808414 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04808414's enrollment target sits among peer trials
104 536th of 2000 higher than 1,460 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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