318
Participants
Start Date
July 13, 2022
Primary Completion Date
June 30, 2026
Study Completion Date
December 31, 2026
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.
COMPLETED
Research Site 127, Richmond
RECRUITING
Research Site 118, Winston-Salem
COMPLETED
Research Site 119, Decatur
RECRUITING
Research Site 102, Doral
RECRUITING
Research Site 103, Miami
RECRUITING
Research Site 140, Jensen Beach
COMPLETED
Research Site 115, Birmingham
COMPLETED
Research Site 114, Royal Oak
COMPLETED
Research Site 117, Northbrook
COMPLETED
Research Site 122, Galveston
COMPLETED
Research Site 141, Edinburg
RECRUITING
Research Site 123, Los Angeles
RECRUITING
Research Site 125, Montebello
COMPLETED
Research Site 143, Chula Vista
RECRUITING
Research Site 137, San Diego
RECRUITING
Research Site 126, Tustin
RECRUITING
Research Site 139, Orange
RECRUITING
Research Site 131, Lancaster
COMPLETED
Research Site 138, Fresno
COMPLETED
Research Site 120, Boston
Lead Sponsor
Collaborators (1)
Parexel
INDUSTRY
Locus Biosciences
INDUSTRY