drugset / Trial / NCT02436876
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
Phase 2
Completed
29 enrolled
Microbion Corporation
Congressionally Directed Medical Research Programs · collabMedpace, Inc. · collabUniversity of California, San Francisco · collabUniversity of Pennsylvania · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.
Timeline
- Start
- 2016-05-24
- Primary completion
- 2017-10-27
- Completion
- 2018-07-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pravibismane | Small molecule | 0.5 ug/m2 | Other |
| Subject | Pravibismane | Small molecule | 1.5 ug/m2 | Other |
| Subject | Pravibismane | Small molecule | 5 ug/m2 | Other |