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MBN-101

Phase 2

Bacterial Infection | Small molecule | Infectious Disease |Medpace Holdings, Inc. Common Stock|Last Updated: Sep 30, 2021

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

MBN-101 · 1 trial · 1 indication

Phase 2 1
NCT02436876Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone SitesBacterial Infection
COMPLETED29 Analytics
PHASE2COMPLETED
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
Bacterial InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events
12 weeks

This study evaluates the safety and tolerability of single escalating doses of locally administered MBN-101 or placebo, as adjunct to standard of care antimicrobial and surgical therapy.

Secondary Endpoints

Number of Treatment Failures
12 weeks
Treatment Failure in Subjects With Antibiotic-resistant Infections
Up to 12weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSingle, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
Cohort 2EXPERIMENTALSingle, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
Cohort 3EXPERIMENTALSingle, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo

Interventions

NameTypeDescription
MBN-101DRUGMBN-101 is a locally administered, anti-infective drug product
PlaceboOTHERThe placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * To be eligible for this study, each of the following criteria must be satisfied with a "YES" answer (unless not applicable): Patients who: * have had operative fracture fixation of the upper extremity (AO/OTA class 15, 11-13, 21-23), lower extremity (AO/OTA class 31-34, 41 4...

Countries:United States
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