A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI

NCT02723539 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MBN-101-202
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. All patients will also receive systemic antibiotic treatment.

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with treatment-related adverse events

  Safety and tolerability will be assessed by treatment-related adverse events

  From the start of dosing upto 4 weeks following the completion of dosing

• Proportion of participants who are clinically cured

  Clinical cure is defined as the resolution of clinical signs and symptoms of infection 2 weeks following the end of treatment (EOT)

  2 weeks following completion of dosing (up to 5 weeks)

Secondary Outcomes (1)

• Proportion of participants who are microbiologically cured

  2 weeks following completion of dosing (up to 5 weeks)

Study Arms (2)

MBN-101

EXPERIMENTAL

MBN-101: a suspension of 150, 375, or 600 microgram (µg)/milliliter (mL) (w:v) BisEDT drug particles in suspension in 3% methylcellulose / 0.5% polysorbate 80 / 10 millimole (mM) sodium chloride / 10 mM sodium phosphate.

Drug: MBN-101

Vehicle

PLACEBO COMPARATOR

MBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate

Drug: Placebo

Interventions

MBN-101 DRUG

Topical application

Also known as: BisEDT

MBN-101

Placebo DRUG

Topical application

Also known as: Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria
• Has a foot infection as defined by the IDSA guidelines, with a severity rating of moderate or severe
• Either no current or recent (within 72 hours) antibiotic therapy for the DFI,
• Has documented adequate arterial perfusion in the affected limb (either palpable dorsalis pedis or posterior tibial pulses, or normal Doppler wave forms, or a toe blood pressure ≥ 45 mm Hg, or an ankle-brachial index (ABI) of \>0.6)

You may not qualify if:

• Proven or highly suspected, involvement of bone (i.e., osteomyelitis)
• More than one concurrent, infected, diabetic foot ulcer
• Hemoglobin A1c \> 11 on the day of presentation
• Requirement for ongoing immunosuppressive therapy (topical or inhaled corticosteroids are permitted)
• Serum creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase \>2 times the upper limit of the normal range of the local testing laboratory
• Absolute neutrophil count \<1000
• Any condition that has required treatment with any other bismuth containing compound within the last 2 weeks (i.e., Kaopectate or Pepto-Bismol)
• Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months
• Need for any surgical therapy beyond debridement to treat the diabetic foot ulcer (e.g., incision and drainage, removal of necrotic tissue)
• Planned lower extremity amputation that will include their infected ulcer
• Known allergy to bismuth and/or MBN-101 excipients (methylcellulose, Tween 80 (polysorbate 80))
• Female patients who are pregnant, lactating, or who have a positive serum human chorionic gonadotropin (pregnancy) as determined by laboratory testing
• Immunocompromised due to illness or organ transplant
• History of any type of cancer (excluding non-melanoma localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix)
• History of major medical noncompliance

Sponsors & Collaborators

• Microbion Corporation: lead

Study Sites (2)

Limb Preservation Platform, Inc

Fresno, California, 93710, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

Related Publications (1)

• Lipsky BA, Kim PJ, Murphy B, McKernan PA, Armstrong DG, Baker BHJ. Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double-blind, placebo-controlled trial. Int Wound J. 2024 Apr;21(4):e14817. doi: 10.1111/iwj.14817.

  PMID: 38567778 DERIVED

MeSH Terms

Interventions

1,2-ethanedithiol

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 30, 2016
• Study Start: March 6, 2017
• Primary Completion: November 1, 2017
• Study Completion: July 26, 2019
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)