Evaluation of Pharmacokinetics, Relative Bioavailability, and Safety of PA-101 in Healthy Subjects, Patients with Systemic Mastocytosis, and Patients with Allergic Asthma - PA-101-01

Patara Pharma, LLC0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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

•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

发起方