A Study of MRx-4DP0004 in Asthma

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twice daily in addition to their existing asthma medication for 12 weeks. Safety and tolerability and immune modulatory effects of MRx-4DP0004 will be assessed throughout the study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 4D pharma plc

Criteria

Inclusion Criteria:

• Documented history and diagnosis of asthma at least 6 months prior to Visit 1.

• Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.

• ACQ-6 score >1.5 and <=4

• FEV1 >50% of predicted normal

• Following protocol specified contraception requirements.

Exclusion Criteria:

• Non-compliant with prescribed asthma maintenance treatment.

• At significant risk of exposure to a change in environmental sensitising substances during the study.

• Co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study.

• Hepatitis B or C or HIV.

• GI fistula, feeding tubes or inflammatory bowel disease.

• GI disease resulting in inability for oral intake, malabsorption syndrome, surgical procedures affecting absorption, uncontrolled inflammatory bowel disease.

• History of life-threatening asthma.

• Systemic corticosteroids within 6 weeks of first dose.

• Allergy to all of ampicillin, clindamycin and imipenem.

• Probiotic supplements.

• Immunosuppression or immunosuppressant medication.

• Use of ICS and LABA as Maintenance and Reliever Therapy.

• Smokers or nicotine users within 3 months of screening.

• Former smokers >15 pack years.

• Systemic antibiotics within 6 weeks of first dose.

• Clinically significant haematology and serum biochemistry.

• Sensitivity to any constituent of IMP.

• Diastolic blood pressure <45 or >90, systolic blood pressure <95 or >155mmHg, Pulse rate <40 or >100 bpm.

• Clinically significant ECGs or structural cardiac abnormalities.

• Any other condition that may interfere with primary objective.

• Receipt of a positive COVID-19 test result within 4 weeks of first dose of IMP