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R-3750

Phase 1

Crohn Disease (CD) | Small molecule | Gastrointestinal |cbdMD, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

R-3750 · 1 trial · 1 indication

Phase 1 1
NCT07791888R-3750 in Patients With Crohn's DiseaseCrohn Disease (CD)
NOT YET_RECRUITING40 Analytics
PHASE1NOT YET_RECRUITING
R-3750 in Patients With Crohn's Disease
Crohn Disease (CD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Adverse Events.
From first dose through Day 168 end of study

Number of participants experiencing one or more treatment-emergent adverse events following administration of R-3750 or placebo.

Secondary Endpoints

Number of participants with serious adverse advents
From first dose through Day 168 end of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeksEXPERIMENTALParticipants randomized to the experimental arm will receive R-3750 at a dose of 9E10 colony-forming units (CFU) per day, administered orally once daily from Day 1 through Day 84 (12 weeks).
Arm 2: Matching placebo orally once daily for 12 weeksPLACEBO_COMPARATORParticipants randomized to the placebo comparator arm will receive matching placebo administered orally once daily from Day 1 through Day 84 (12 weeks).

Interventions

NameTypeDescription
R-3750DRUGR-3750 DP is a live biotherapeutic product consisting of Lactococcus lactis engineered to express Surface Layer Protein A (SlpA), formulated in enteric-coated capsules for oral administration. Participants randomized to R-3750 will receive 9E10 colony-forming units (CFU) per day orally once daily from Day 1 through Day 84.
PlaceboDRUGMatching placebo will be administered orally once daily from Day 1 through Day 84.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age 18 to 80 years, inclusive, at the time of informed consent. * Able and willing to provide written informed consent and comply with study procedures and study visits. * Documented diagnosis of Crohn's disease with symptoms/onset of disease at least 3 months prior to Screeni...

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