HAL-MPE1 First-in-human

Inclusion criteria

• Signed informed consent.
• Male or female subjects aged 18-65 years.
• A well-documented medical history of systemic reactions after ingestion of peanut
• Positive food challenge at ≤1.5 gram peanut protein ingestion within the last 2 years
• Positive serum specific anti-peanut and Ara h 2 Immunoglobulin E (IgE-test) (>0.7 kiloUnits(kU)/L) within the last 2 years
• Forced expiratory volume at one second (FEV1)>70% of predicted value

Exclusion criteria

• Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence) during challenge with peanuts.
• Baseline serum tryptase level >20 µg/l
• Known allergy or known hypersensitivity to (placebo) excipients
• Participation in any interventional study aimed at desensitizing the peanut allergy in the past
• Any specific immunotherapy (SCIT, SLIT or OIT) during the study period
• Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
• Significant active malignancies or any malignant disease within the past 5 years
• Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: any severe or unstable lung diseases; endocrine diseases; clinically significant renal or hepatic diseases, or haematological disorders; or severe ongoing symptomatic allergic diseases
• History of cardiovascular disease, uncontrolled hypertension or arrhythmias
• Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
• Use of systemic steroids within 4 weeks before start of the study and during the study
• Treatment with β-blockers/ACE inhibitors
• Vaccination within one week before start of therapy or during study
• Anti-IgE/anti-Tumor necrosis factor (TNF) therapy or any biologic immunomodulatory therapy within the 6 months prior to inclusion and during the study
• Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
• Pregnancy (test performed at screening), lactation or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)
• Alcohol, drug or medication abuse within the past year
• Any clinically significant abnormal laboratory parameter at screening
• Lack or expected lack of cooperation or compliance
• Severe psychiatric, psychological, or neurological disorders
• Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators