Chronic Asthma and/or COPD MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: N.A.
Product Code: FP-025
Pharmaceutical Form: Capsule
INN or Proposed INN: N.a.
CAS Number: 877176-23-3
Current Sponsor code: FP-025
Other descriptive name: 5-[3-[[4-[(3-METHYLPHENYL)ME
Sponsors
Foresee Pharmaceuticals co, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females or males, between 18 and 55 years of age at Screening, inclusive, on the day of signing the Informed Consent Form (ICF). 2. 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. 3. Subject has a BMI = 18.0 kg/m2 and = 32.0 kg/m2 (and weighs =50 kg). 4. Subjects have been diagnosed with asthma cf GINA guidelines. 5. Subjects should have established allergy for HDM (serum HDM-specific IgE or positive SPT at Screening or documented within 1 year pre-screening). 6. 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). 7. FEV1 should be =70% of predicted on Screening Day 2. 8. On Screening Day 2, PC20FEV1(Meth) should be =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Subject has any active and/or chronic (physical or mental) condition requiring maintenance (pharmaco)therapy or which otherwise precludes subject from safe or adequate study participation (ineligibility will be assessed by the PI). 2. Subject has a history of cancer (exception: localized basalioma or cervix carcinoma in situ). 3. Subject had any major (nasal) surgery in the 6 months before Screening Day 1. 4. Subject is pregnant or lactating. 5. Subject is using immunotherapy that according to the PI may interfere with the study (e.g. in case of immunotherapy with HDM or when subject is in the updosing phase of any immunotherapy). 6. Subject regularly used alcohol (intake of >21 units/wk for males and >14 units/wk for females) and/or recreational drugs within the last 6 months prior to screening. 7. Subject had any respiratory (viral) infections (e.g. common cold) within 3 weeks of Screening Day 1 or on Day -1. 8. 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. 9. Subject is using prohibited medications as detailed in the protocol. 10. 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. 11. Subject has any known allergic response for the medications used or known severe allergic reactions or anaphylaxis (to food/medications/insect venoms). 12. Subject participated in medical studies in the past 3 months (non-biologicals) or in the past 6 months (biologicals). 13. Subject is anticipated not to comply with study medication or other aspects of the study (at the discretion of the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of FP-025 vs placebo on the allergen (HDM)-induced late asthmatic response expressed as FEV1 AUC3-8h in subjects with clinically stable, mild allergic asthma and blood eosinophilia.;Secondary Objective: To determine the pharmacodynamics of FP-025 vs placebo (in blood, exhaled air, additional markers of airway physiology) following inhaled HDM challenge in subjects with clinically stable, mild allergic asthma and blood eosinophilia. To determine the safety and tolerability of multiple oral doses of FP-025 vs placebo in subjects with clinically stable, mild allergic asthma and blood eosinophilia. To assess the pharmacokinetics of FP-025 vs placebo during the allergen challenge day in subjects with clinically stable, mild allergic asthma and blood eosinophilia.;Primary end point(s): The primary endpoint of this study is the effect of study treatments on FEV1 AUC3-8h during the LAR (FP-025 vs placebo).;Timepoint(s) of evaluation of this end point: After database lock, before clinical study report. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pharmacodynamic endpoints include the effect of study treatments on: o HDM-induced LAR expressed as max% fall in FEV1 from post-diluent baseline; o HDM-induced early asthmatic response (EAR) expressed as FEV1 AUC0-3h; o HDM-induced EAR expressed as max% fall in FEV1 from post-diluent baseline; o Changes in airway hyperresponsiveness expressed as PC20FEV1(Meth) (Day 1-Day 10 and Day 10-Day 12); o Small airway parameters following HDM-challenge (i.e. R5, R5-R20, X5, Fres; o Fractionated nitric oxide (FeNO); o Blood eosinophils. • Safety parameters include physical examination, clinical signs/symptoms reporting (MedDRA), (S)AEs, vital signs, lung function measurements, ECG and clinical safety laboratory outcomes (blood/urine). • Pharmacokinetic parameters of FP-025 in blood (plasma) include Cmax, tmax and AUC0-tau. ;Timepoint(s) of evaluation of this end point: After database lock, before clinical study report. | — |
Countries
Netherlands
Contacts
Public ContactDavid Lau, Ph.D.
Foresee Pharmaceuticals Co., Ltd.
Outcome results
None listed