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NCT04191148 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli
A Phase 1 study, sponsored by Locus Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT04191148: Completed Phase 1 study, sponsored by Locus Biosciences.
NCT04191148 is a Phase 1 study that has completed, run by Locus Biosciences. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04191148, a Phase 1 study, has completed, sponsored by Locus Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Study LBx-1001 is a multi-center randomized, double-blind study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LBP-EC01 in patients with indwelling urinary catheters, or requiring intermittent catheterization, and/or patients with asymptomatic bacteriuria caused by Escherichia coli (E. coli). This study population has been selected because LBP-EC01 is a phage cocktail where active bacterial host engagement is required to allow for amplification of the phage and evaluation of the safety and PK of the phage cocktail. Eligible patients will require confirmation of colonization with a urine sample taken within 10 days of randomization that cultures contain ≥10\^3 E. coli colony forming unit (CFU)/mL, without the patient having clinical signs or symptoms of an active urinary tract infection (UTI) requiring antibiotic treatment. Patients should have E. coli as the primary colonizing bacteria and must not have a secondary bacterial colonization at levels equal to or greater than that seen from E. coli.
Primary Outcome
Safety and tolerability of LBP-EC01: Number of participants with treatment-related adverse events as assessed by DAIDS v2.1
Interventions
- DRUG Placebo
- DRUG LBP-EC01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-12-30 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 1 |
What the finished NCT04191148 record still lists
NCT04191148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04191148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04191148 about?
NCT04191148 is a clinical study titled "Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli". Study LBx-1001 is a multi-center randomized, double-blind study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LBP-EC01 in patients with indwelling urinary catheters, or requiring intermittent catheterization, and/or patients with asymptomatic bacteriuria caus...
What is the current status of trial NCT04191148?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-12-30. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT04191148?
The interventions under investigation include: Placebo (DRUG), LBP-EC01 (DRUG).
Who is sponsoring clinical trial NCT04191148?
This trial is sponsored by Locus Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04191148's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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