NCT03824795

Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

Completed Phase 2 Last updated 15 April 2020

What this trial tests

Phase 2 trial testing MGB-BP-3 in Clostridium Difficile Infection in 34 participants. Completed in 3 April 2020.

Timeline

7 February 2019

Primary endpoint
3 April 2020

3 April 2020

Quick facts

Lead sponsor	MGB Biopharma Limited
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	7 February 2019
Primary completion	3 April 2020
Estimated completion	3 April 2020
Sites	9 locations across Canada, United States

Drugs / interventions tested

• MGB-BP-3 — full drug profile →

Conditions studied

• Clostridium Difficile Infection — all drugs for Clostridium Difficile Infection →

Sponsor

MGB Biopharma Limited

Who can join

18 and older, any sex, with Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibiotics in the clinical pipeline in October 2019.
   Butler MS, Paterson DL. · · 2020 · cited 174× · PMID 32152527 · DOI 10.1038/s41429-020-0291-8
2. Antibiotics in the clinical pipeline as of December 2022.
   Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
3. A Review of Antibacterial Candidates with New Modes of Action.
   Butler MS, Vollmer W, Goodall ECA, Capon RJ, et al · · 2024 · cited 49× · PMID 39018341 · DOI 10.1021/acsinfecdis.4c00218
4. Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.
   Koulenti D, Xu E, Song A, Sum Mok IY, et al · · 2020 · cited 27× · PMID 32019171 · DOI 10.3390/microorganisms8020191
5. Insights into the Spectrum of Activity and Mechanism of Action of MGB-BP-3.
   Hind C, Clifford M, Woolley C, Harmer J, et al · · 2022 · cited 20× · PMID 36444998 · DOI 10.1021/acsinfecdis.2c00445
6. The Urgent Threat of <i>Clostridioides difficile</i> Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects.
   Alshrari AS, Hudu SA, Elmigdadi F, Imran M. · · 2023 · cited 17× · PMID 36830964 · DOI 10.3390/biomedicines11020426
7. Multitargeted anti-infective drugs: resilience to resistance in the antimicrobial resistance era.
   Suckling CJ, Hunter IS, Scott FJ. · · 2022 · cited 15× · PMID 35600289 · DOI 10.4155/fdd-2022-0001
8. Antibacterials with Novel Chemical Scaffolds in Clinical Development.
   Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x