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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 is a Phase 1 study that has completed, run by Locus Biosciences. The registered enrollment target is 36 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04191148
The ClinicalTrials.gov registry entry for NCT04191148 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Locus Biosciences, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04191148 reports 0 study locations.
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.
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