Recruiting
Phase 2

LBP-EC01

Sponsor:

Locus Biosciences

Code:

NCT05488340

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LBP-EC01 0.1 x IV dose

LBP-EC01 0.01x IV Dose

LBP-EC01 IV Infusion Dose

Placebo

LBP-EC01

Study Details

Brief summary:

This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.

Conditions

Urinary Tract Infections

Study ID

NCT05488340

Start date

Jul 13, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli (as single pathogen or part of polymicrobial infection where E. coli is the predominant pathogen). Please note that the current infection can be used to meet the requirement of AMR E. coli documentation.
  • Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
  • Active acute uUTI infection defined by:

a. Evidence of pyuria: i. >10 white blood cell (WBC)/mL3 on microscopic evaluation of spun, clean, mid-stream urine specimen or >3 WBC/high power field on unspun clean, mid-stream urine specimen, AND/OR ii. Dipstick analysis of a clean, mid-stream urine specimen positive for leukocytes, AND b. At least 2 of the following signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, or suprapubic pain
  • Willing to comply with all aspects of study design including study restrictions, blood, urine, and stool sampling, and scheduled study visits.
  • All sexually active female patients of childbearing potential must use highly effective contraception during the study and until 2 weeks after the last dose of study drug treatment.
  • Agrees to STOP continuous low dose antimicrobial prophylaxis and/or will maintain the same practices for post-coital antimicrobial prophylaxis to prevent UTI, as during the prior 12-months, for the entire study duration (throughout the 6-month follow-up period or study discharge).
  • Agrees to not use any prescription or non-prescription medication for the microbiological or symptomatic treatment of the presenting acute uUTI for the first 10 days of the study.
  • Capable of providing their own signed informed consent form (ICF) prior to any study-related procedures being performed.
  • If participating in Part 1 of the study, agrees to fast for ≥2 h prior to first dose of study drug on Day 1/Visit 1 except for drinking 240 mL of water with study drug administration.

Exclusion Criteria:

  • Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/ Celsius, shaking chills, or other clinical manifestations suggestive of complicated UTI.
  • Treatment with other antibacterial drugs including those that are effective for treatment of the acute uUTI or prevention of recurrent UTI in the 5 days prior to Screening unless the recovered pathogen demonstrates resistance to the initial antibiotic and clinical symptoms persist. In postmenopausal women vaginal estrogen replacement therapy is permitted so long as patient meets all other eligibility criteria, that the dose and regimen has be stable for > 3 months from Screening (D1/V1), and that there is no planned change to therapy through the 6-month follow-up period or study discontinuation.
  • Clinical symptoms for more than 5 days before Screening.
  • Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities that increase UTI risk or lead to a post void residual (PVR) urine volume > 150mL, poorly controlled diabetes mellitus (diagnosed but is not being treated/managed by a physician's care or HbA1c >8), current symptomatic or larger than 5mm renal calculi, or advanced renal dysfunction (determined by eGFR < 45 mL/min/1.73 m2). Patients with vaginal prolapse beyond the hymen with Valsalva (e.g., when coughing).
  • Individuals considered to be immunocompromised.
  • Clinically significant serious unstable physical illness that in the investigator's opinion prevents patient from completing the study or prevents interpretation or resolution of clinical symptoms.
  • Pregnant or nursing women.
  • Exposure to any investigational drugs or other phage therapy 30 days prior to Screening (D1/V1) or prior to participation in this study. Patients who participate in Part 1 are not eligible for participation in Part 2.
  • Allergies to excipients of the study drug or antibiotics.
  • History of autonomic dysreflexia.
  • History of intravenous (IV) drug abuse or is currently using or has positive results for drugs of abuse at screening.
  • Patients who reside in a long-term care facility.
  • Suspected or confirmed acute coronavirus disease 2019 (COVID-19) or recent COVID-19 infection with ongoing symptoms.

Study Design

Enrollment

318 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1- Arm 4 (previously 1)

Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10\^11 PFU) and oral TMP/SMX on D1 through D3.

experimental: Part 1- Arm 5 (previously 2)

Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10\^10 PFU) and oral TMP/SMX on D1 through D3.

experimental: Part 1- Arm 6 (previously 3)

Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 infusion (1x10\^12 PFU) and oral TMP/SMX on D1 through D3.

experimental: Part 2: LBP-EC01

LBP-EC01 given by dose regimen selected from Part 1. IU LBP-EC01 on D1 and D2 with IV LBP-EC01 (1x10\^11 PFU) and oral TMP/SMX on D1 through D3.

placebo comparator: Part 2: Placebo

Placebo given by dose regimen selected from Part 1. IU placebo on D1 and D2 with IV placebo and oral TMP/SMX on D1 through D3.

Interventions

LBP-EC01 0.1 x IV dose

Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.6mL of LBP-EC01 (approximately 1x10\^11 PFU) diluted in 0.4mL of Lactated Ringer's solution given on Days 1 through Day 3.

LBP-EC01 0.01x IV Dose

Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.06 mL of LBP-EC01 (approximately 1x10\^10 PFU) diluted in 0.94 mL of Lactated Ringer's solution given on Days 1 through Day 3.

LBP-EC01 IV Infusion Dose

Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous infusion dose of 6mL of LBP-EC01 (approximately 1x10\^12 PFU) diluted in 94 mL of Lactated Ringer's solution given over 2 hours on Days 1 through Day 3.

Placebo

Dose regimen selected from Part 1 of placebo (Tris buffer).

LBP-EC01

Dose regimen selected from Part 1 of LBP-EC01 (1x10\^10 - 1x10\^13 PFU) per dose.

TMP/SMX

TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.

Primary outcome measure

  • Part 1: Levels of LBP-EC01 in urine and blood measured by quantitative plaquing assay across the treatment period and over 48 h after the last dose [ Time Frame: Day 1 to Day 5 ]
  • Part 2: Proportion of patients with resolution of clinical symptoms and microbiologic response of uUTI caused by drug resistant E. coli as defined at Day 10 test of cure (TOC). [ Time Frame: Day 10 ]

Central Contacts and Locations

Central contacts

Locus Clinical Operations

(919) 495-4510clinicaloperations@locus-bio.com

Paul Kim

(919) 495-4510Paul.kim@locus-bio.com

Locations

Research Site 131

Recruiting

Lancaster, California, United States, 93534

Research Site 123

Recruiting

Los Angeles, California, United States, 90027

Research Site 152

Recruiting

Murrieta, California, United States, 92563

Research Site 137

Recruiting

San Diego, California, United States, 92037

Research Site 126

Recruiting

Tustin, California, United States, 92780

Research Site 102

Recruiting

Doral, Florida, United States, 33166

Research Site 151

Recruiting

Hialeah, Florida, United States, 33013

Research Site 103

Recruiting

Miami, Florida, United States, 33176

Research Site 149

Recruiting

Miami, Florida, United States, 33176

Research Site 153

Recruiting

Ocala, Florida, United States, 34473

Research Site 154

Recruiting

St Louis, Missouri, United States, 63141

Research Site 145

Recruiting

Raleigh, North Carolina, United States, 27708

More Information

Sponsor

Locus Biosciences

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • LBP-EC01
  • Urinary tract infection
  • E. coli
  • Bacteriophage
  • Phage
  • crPhage
  • Recombinant bacteriophage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Locus Biosciences on 2026-03-20.