Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a single IV dose of N6022 will have a significant bronchoprotective effect, compared with placebo, during methacholine challenge.

Detailed Description
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The number of patients with adverse events measured in both the treated and placebo groups from start of dosing until Day 28 post dose.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Two-Period, Cross-Over Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Active
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at screening. Patient has a ≤ 5 pack years smoking history and nonsmoking for ≥ one year. Documented history of mild bronchial asthma, first diagnosed at least 6 months and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation. Pre-bronchodilator FEV1 ≥ 75% of predicted at screening. Sensitivity to methacholine with a provocation concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of ≤ 8 mg/ml at screening. Demonstrated stable lung function during screening with ≤10% variability between two assessments of FEV1 taken at least 7 days apart at approximately the same time of day. Exclusion Criteria: Hypertension at screening is defined as systolic blood pressure (BP) >150 mmHg or diastolic BP > 90mmHg. Respiratory tract infection and/or exacerbation of asthma within prior 4 weeks History of life-threatening asthma Administration of steroids within 4 weeks of the screening visit. History of being unable to tolerate or complete MCh testing. Blood donation (500 mL) within 3 months of starting the clinical study. Tested positive for hepatitis C antibody or hepatitis B surface antigen. Tested positive for human immunodeficiency virus (HIV) antibodies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>N6022 - 5 mg | Drug: Active<br>* A 5 mg single dose given intravenously via syringe pump over 1 minute.<br>* Other names: N6022;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Same as active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing | These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing | These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7. | 8 hours | 
| To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma. | Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed. | 10 Weeks |