The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).
This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD. Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the end of the treatment period, patients will be followed for up to 8 weeks to assess the incidence of disease recurrence.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
MGB-BP-3
Florida International Medical Research
Miami, Florida, United States
Omega Research Maitland LLC
Orlando, Florida, United States
Snake River Research PLLC
Idaho Falls, Idaho, United States
Ochsner Clinic Foundation Infectious Disease Research
Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.
Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).
Time frame: 40 days
Initial cure rate at 12 days post initiation of therapy.
Initial clinical cure is defined as resolution of diarrhea (\<3 bowel movements with unformed stools within 24 hours \[Type 5, 6, or 7 bowel movement on the Bristol Stool Chart\] for patients for 2 consecutive days), maintained for the subsequent duration of therapy (1 day of exacerbation and then return to the resolved state is acceptable), with no further requirement for CDAD therapy, assessed by EOT and sustained for 2 days after the end of the 10-day initial treatment course.
Time frame: 12 days
CDAD Recurrence
Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.
Time frame: Up to 8 weeks
Peak plasma concentration (Cmax).
Days 1, 5 and 10.
Time frame: 10 days
Time to peak plasma concentration (Tmax).
Days 1, 5 and 10.
Time frame: 10 days
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