MGB-BP-3 - first doses in humans. version 1
Research type
Research Study
Full title
A single-centre, double-blind, placebo-controlled, study in healthy men to assess the safety and tolerability of single and repeated ascending doses of MGB-BP-3 (14-019)
IRAS ID
173363
Contact email
Sponsor organisation
MGB Biopharma Ltd
Eudract number
2015-000489-73
Duration of Study in the UK
1 years, 0 months, days
Research summary
Oral MGB-BP-3 is a potential new antibiotic treatment for Clostridium difficile infections (CDIs). CDIs are a type of bacterial infection that can affect the digestive system, and usually occur in patients who’ve had certain antibiotics, as those antibiotics can affect normal gut bacteria that protect against C. difficile.
Recently, a new strain of C. difficile has emerged, which causes more severe CDI and is more resistant to exisiting antibiotic treatments. MGB-BP-3 works in a different way to existing antibiotics, so we hope that it’ll be more effective in treating CDIs, including the new strain.
We need to test MGB-BP-3 in healthy people before it’s tested in patients. We’ll test single and repeated doses of MGB-BP-3, as a capsule by mouth, to ascertain its potential safety and tolerability. We’ll also measure levels of MGB-BP-3 in blood, urine and faeces.
This study will be done in 2 parts. The study will include 40 healthy volunteers, aged 18-45 years, as follows:• Part A: 16 participants will have single doses of MGB-BP-3 or placebo. MGB-BP-3 has never been given to humans before, so we'll start with a small dose, and increase gradually as the study progresses. Each participant will have 3 study sessions; in each session they'll stay on the ward for 4 nights, during which they’ll have a single dose.
• Part B: 24 participants will each have 19 doses of MGB-BP-3 or placebo over 10 days. We plan to increase the dose as the study progresses. Volunteers will stay on the ward for 14 nights in one study session.
Participants will take up to 8 weeks to finish the study, which includes a follow-up visit approximately 1 week after their last dose.
The study will take place at 1 centre in London.
A pharmaceutical company (MGB Biopharma Ltd) is funding the study
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0237
Date of REC Opinion
16 Apr 2015
REC opinion
Favourable Opinion