E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001705 |
E.1.2 | Term | Allergic asthma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of MEM 1414 compared to placebo on the late asthmatic response following an inhaled allergen challenge, as measured by changes in FEV1 compared to baseline. |
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E.2.2 | Secondary objectives of the trial |
1. To assess the efficacy of MEM 1414 compared to placebo on the late asthmatic response following an inhaled allergen challenge, as measured by • Changes in allergen-induced airway hyperresponsiveness (via pre- versus 24-hour post-allergen challenge PC20 methacholine values) • Changes in the following biomarkers of allergen-induced airway inflammation compared to baseline: Exhaled nitric oxide (eNO), Various chemical mediators of inflammation 2. To investigate the safety and tolerability of MEM 1414 compared to placebo in steroid-free subjects with mild allergic asthma. 3. To characterize the pharmacokinetic profile of MEM 1414 in steroid-free subjects with mild allergic asthma.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects between the ages of 18 and 55 years (inclusive). 2. Non- or ex-smokers who are expected to not smoke for the duration of the trial (an ex-smoker being defined as someone with <10 pack-year history and who has completely stopped smoking for at least 12 months before screening for this study). 3. Clinically stable, steroid-free mild allergic asthmatics who: • Have had a well-established, documented asthma diagnosis for at least 6 months prior to screening for this study • Have a forced expiratory volume in one second (FEV1) greater than or equal to 70% of predicted for age and height on Screening Days 1 and 2 • Do not require any controller drugs for asthma • Have been on an as needed regimen of short acting beta 2-agonists. 4. In the previous year or at screening, a positive allergen skin prick test (SPT) wheal response to House Dust Mite (HDM). 5. At screening, a demonstrated airway hyperresponsiveness to methacholine chloride, with a provocative concentration resulting in a 20% decrease in FEV1 (PC20FEV1) of 16 mg/mL or less (a PC20 methacholine value within the previous 12 months may be used to make this determination). 6. At screening, a minimum decrease in FEV1 in both the early (0-3 hour) and late (3-10 hour) allergen-induced response of greater than or equal to 20% and greater than or equal to 15% respectively following inhaled allergen challenge. 7. Due to unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study and for a period of 90 days following the last drug administration. Reliable methods of birth control are considered to be: abstinence (not having sex), oral contraceptives (the "pill"), intrauterine device (IUD), Depo-Provera, Norplant, tubal ligation ("tubes tied"), or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Females who do not use an acceptable contraceptive regimen will be allowed to participate in this study only if they are not considered to be of childbearing potential: females who have had a hysterectomy or tubal ligation, are clinically diagnosed infertile, or are in a menopausal state (minimum of a year without menses). Pregnant women are excluded from participation in this study. Because some methods of birth control are not 100% reliable, a negative serum pregnancy test is required at screening. 8. Male subjects must abstain from unprotected sexual intercourse during the study and for a period of 90 days following the last drug administration. 9. Are in good general health and are expected by the investigator to complete the clinical trial as designed. 10. Have voluntarily provided informed consent and have signed an informed consent form (ICF) indicating that the purpose of the study has been explained, and are willing and able to adhere to the study regimen and study procedures described in the ICF.
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E.4 | Principal exclusion criteria |
1. Any hospitalizations due to asthma in the past 3 years. 2. Treatment with the following medications: • Oral corticosteroids: More than once in the previous 12 months or within 8 weeks of screening • Inhaled or nasal corticosteroids in the previous 4 weeks before screening for this study • A leukotriene receptor antagonist (LTRA), 5-lipoxygenase inhibitor, theophylline or cromones (e.g. cromolyn, nedocromil) in the previous 2 weeks before screening for this study • Long-acting beta2-agonists (LABA) or anticholinergics in the previous 7 days before screening for this study • Short-acting antihistamines and tranquilizers in the previous 7 days before screening for this study • Long-acting antihistamines in the previous 2 weeks before screening for this study • Anti-IgE in the previous 6 months before screening for this study. • Previous treatment with immunotherapy • Vaccinations (e.g. anti-influenza) in the previous 3 months before screening for this study • Antidepressants within the previous 2 weeks before screening for this study. • β-adrenoreceptor blocking agents within the previous 3 days before screening for this study. 3. Significant illness or disease other than asthma. 4. History of severe hypersensitivity or allergy to any drug. 5. Symptomatic allergic rhinitis (those with a history of allergic rhinitis may participate if asymptomatic at screening and, if in the opinion of the investigator, it is unlikely that disease exacerbation will occur during the course of the study). 6. Presence of any active respiratory tract infection, whether bacterial, viral, or fungal in origin within 3 weeks of screening. 7. Have unstable cardiovascular, gastrointestinal, hepatic, musculoskeletal, metabolic, endocrine, neurological or psychiatric disease or have had any clinically significant medical condition other than asthma within 1 month (30 days) prior to screening. 8. Have rheumatoid arthritis, a connective tissue disorder, or any other condition known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease). 9. Major surgery in the past 3 months before screening. 10. Have evidence of significant renal insufficiency, indicated by a serum creatinine greater than the upper limit of normal at screening. 11. Have either of the following liver test abnormalities at screening: • Aspartate transaminase (AST) or alanine transaminase (ALT) 1.5 times greater than the upper limit of normal • Total bilirubin greater than 1.2 times the upper limit of normal. 12. Have insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus, as evidenced by HbA1C level greater than or equal to 8.0% at screening. 13. Have a history of malignancy other than in situ tumors. 14. Have a history of bone disease (e.g., osteoporosis, osteopenia) or suffered from a bone fracture in the previous 12 months before screening. 15. Have any of the following hematologic abnormalities at screening: • Hemoglobin < 10 g/dl • White blood cell (WBC) count <3.0 x 103/mm3 • Platelet count <100,000/mm3. 16. Males with QT/QTc values greater than 450 msec or females with QT/QTc values greater than 460 msec at screening. 17. Are known to have or be a carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody (unless confirmatory tests are negative). 18. Have significant blood loss (>500 ml) or donated blood in the 30 days before screening. 19. Have participated in a clinical trial, where Investigational Product was received, in the previous 3 months before screening for this study. 20. Have a positive urine drug screen (UDS), which includes cotinine, at screening. 21. Recent (<1 year) history of alcohol dependency. Subjects who have a positive alcohol breathalyzer test at screening. 22. Any other reason that may preclude study participation, as determined by the Investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Database lock. This is the Company's standard definition of end of trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |