Blood and Lymphatic System Disorders
Conditions
Interventions
The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
(ECG, vital signs
spirometry). Furthermore a blood and urine sample will be
taken for laboratory tests and an alcohol breath test and drug screen will be
done.
During the stay in the clinic the subject will receive t
Sponsors
Patara Pharma, LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part 1: 1.Male or female volunteers 18-45 years of age, inclusive 2.FEV1 >= 90% of predicted normal value during the screening 3.Body weight above 50 kg and Body Mass Index (BMI) of 18-25, inclusive;Part 2: 1.Male or female subjects 18-65 years of age, inclusive 2.Clinical diagnosis of Indolent Systemic Mastocytosis (ISM) 3.Stable systemic mastocytosis 4.Body weight >50 kg and BMI of 18-28, inclusive;Part 3. 1.Male or female subjects 18-45 years of age, inclusive 2.Clinical diagnosis of allergic asthma 3.Pre-bronchodilator FEV1 >= 70% predicted
Exclusion criteria
Exclusion criteria: Part 1: 1. Any condition that could put the subject at risk or compromise the quality of the study data 2.An upper or lower respiratory tract infection within 4 weeks of study start 3.Current smoker ;Part 2: 1.Smouldering systemic mastocytosis, aggressive systemic mastocytosis, mast cell leukemia, or systemic mastocytosis with an associated clonal hematologic non-mast cell disorder 2.Any condition that could put the patient at risk or compromise the quality of the study data as determined by the investigator 3.History of systemic corticosteroid or immunosuppressive therapy within 6 months of study start;Part 3: 1.Any condition that could put the patient at risk or compromise the quality of the study data as determined by the investigator 2.Pollen sensitized and currently symptomatic asthma 3.Use of corticosteroids within 3 months of study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
Netherlands
Outcome results
None listed