The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.

Inclusion Criteria

The following criteria must be met by all subjects considered for study participation:

• Females or males, between 18 and 55 years of age at Screening, inclusive, on the day of signing the Informed Consent Form (ICF).
• Apart from a clinically stable asthma and HDM-allergy, subjects should be generally healthy with no history of a clinically relevant medical condition that in the opinion of the investigator might interfere with successful study conduct and no clinically relevant abnormalities on medical history, physical exam, vital signs, laboratory parameters or ECG at Screening.
• Subject has a BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 (and weighs ≥50 kg).
• Subjects have been diagnosed with asthma cf GINA guidelines.
• Subjects should have established allergy for HDM (serum HDM-specific IgE or positive SPT at Screening or documented within 1 year pre-screening).
• No severe exacerbation of asthma within past 1 year requiring hospital admission and/or treatment with oral corticosteroids; no (never) intensive care admissions for asthma or intubation).
• FEV1 should be ≥70% of predicted on Screening Day 2.
• On Screening Day 2, PC20FEV1(Meth) should be 21 units/wk for males and >14 units/wk for females) and/or recreational drugs within the last 6 months prior to screening.
• Subject had any respiratory (viral) infections (e.g. common cold) within 3 weeks of Screening Day 1 or on Day -1.
• Subject is using maintenance asthma therapy or long-acting bronchodilators or any other anti-asthma or anti-allergic medications (as detailed in the protocol) other than infrequent use of SABA prn only.
• Subject is using prohibited medications as detailed in the protocol.
• Multi-sensitized symptomatic subjects with seasonal (pollen) allergies should be included outside of the relevant allergen season and/or should not be in frequent contact with the relevant allergen during the study.
• Subject has any known allergic response for the medications used or known severe allergic reactions or anaphylaxis (to food/medications/insect venoms).
• Subject participated in medical studies in the past 3 months (non-biologicals) or in the past 6 months (biologicals).
• Subject is anticipated not to comply with study medication or other aspects of the study (at the discretion of the investigator).