Safety, Blood Levels and Effects of MGB-BP-3

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is to assess the safety and tolerability aspects of oral MGB-BP-3, a treatment for Clostridium difficile infections.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MGB Biopharma Limited
• Collaborators: Analytical Services International Limited; Cambridge Regulatory Services; Hammersmith Medicines Research; Innovate UK; Phases Clinical Research Limited; Synlab Services; Viapath

Criteria

Inclusion Criteria:

• Male

• Body mass index (BMI) of 18.0-30.9 kg/m2

• Normal blood pressure

• healthy on the basis of a clinical history & physical examination

• Normal ECG

• Normal vital signs

• Normal laboratory tests of blood and urine

• Willing to use reliable contraception

• Able to give fully informed written consent

Exclusion Criteria:

• Positive tests for hepatitis B & C

• Positive tests for HIV

• Severe adverse reaction to any drug

• Drug or alcohol abuse

• Smoke more than 5 cigarettes (or use of equivalent tobacco or nicotine products) daily

• Received over-the-counter medication within previous 7 days (with the exception of paracetamol)

• Prescribed medication during previous 28 days

• Participation in other clinical trials of unlicensed medicines

• Loss of more than 400 mL blood, within the previous 3 months

• Vital signs outside the acceptable range

• Clinically relevant abnormal findings at the screening assessment

• Acute or chronic illness

• Clinically relevant abnormal medical history or concurrent medical condition

• Possibility that volunteer will not cooperate.