EUCTR2018-003242-16-GB进行中（未招募）1 期
A first in human, double-blind, placebo-controlled, multicentre Phase I/II study to evaluate the safety, tolerability and immune modulatory effects of MRx-4DP0004, (a lyophilised formulation of Bifidobacterium breve proprietary strain of 4D Pharma Research), in participants taking long-term control medication for their asthma - A first in human study to evaluate safety, tolerability and immune modulatory effects of MRx-4DP0004
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- •2. Participants with a documented medical history and diagnosis of asthma at least 6 months prior to Visit 1.
- •3. Participants who have stable current treatment as per GINA treatment steps 2 to 4 (ICS with or without LABA) for the past 2 months at least.
- •4. Participants who have an ACQ-6 score =1.5 and =4 at screening (V0), =1.0 and =4 at baseline (V2).
- •5. Participants who have FEV1 >50% of predicted normal.
- •6. Male and female participants are eligible to enter provided the following criteria regarding contraception, pregnancy and breast feeding are met.
- •Female participants:
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP)
- •A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 2 menstrual periods after the last dose. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Are non-compliant with prescribed asthma maintenance therapy in the opinion of the Investigator.
- •2. Are at significant risk of being exposed to a change in environmental sensitising substances during the duration of the study (e.g., start or end of pollen season, exposure to sensitising animals etc.) according to Investigator’s judgement.
- •3. Co-morbidities that have not been optimally controlled for the last 3 months. Any significant disease or disorder (e.g., cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the participant at risk because of inclusion in the study, or may influence the results of the study, or the participant’s ability to enter the study.
- •4. Have human immunodeficiency virus (HIV) or active hepatitis B or hepatitis C.
- •5. Participants with known GI fistula, feeding tubes or inflammatory bowel disease.
- •6. Participants with GI disease resulting in an inability to take oral medication, malabsorption syndrome, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn’s, ulcerative colitis).
- •7. Medical history of life-threatening asthma including intubation and intensive care unit admission.
- •8. Participants who use systemic corticosteroids for any reason within 6 weeks of first dose of IMP.
- •9. Participants who are allergic to all the following 3 antibiotics: ampicillin, clindamycin, imipenem.
- •10. Participants using probiotic supplements (probiotic yoghurts are allowed).
- •11. Participants who are immunosuppressed or receiving immunosuppressant medication.
- •12. Participants using ICS - LABA combination as both Maintenance And Reliever Therapy (MART regimen).
- •13. Current smokers or nicotine users in any form including e-cigarettes and nicotine patches or sprays or participants who have smoked/used nicotine in the 3 months prior to Screening.
- •14. Former smokers with >15 pack years.
- •15. Participants who have completed a course of systemic antibiotics in the 4 weeks prior to first dose of IMP.
- •16. Participants with clinically significant abnormal, in the opinion of the Investigator, values for haematology and serum biochemistry results at Screening.
- •17. Participants who have a known sensitivity to any of the constituents of the IMP.
- •18. Diastolic blood pressure <45 or >90 mmHg, systolic blood pressure <95 or >155 mmHg, and/or a pulse rate <40 or >100 beats per minute (bpm) after resting for 5 minutes.
- •19. Participants with clinically significantly abnormal ECGs or structural cardiac abnormalities e.g. structural or valvular heart defects, patent foramen ovale.
- •20. Any condition that, in the opinion of the Investigator, might interfere with the primary study objective.
研究者
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