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

Completed

• Conditions: 10006436; Blood and Lymphatic System Disorders; Systemic Mastocytosis; Mastocytosis and Asthma; 10001708

• Registration Number: NL-OMON41045
• Lead Sponsor: Patara Pharma, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>safety</p><br>