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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nivalis Therapeutics, Inc.

Criteria

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.