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

Nivalis Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Asthma

Treatments

Drug: Placebo

Drug: Active

Study type

Interventional

Funder types

Industry

Identifiers

NCT01316315

N6022-2A1-02

Details and patient eligibility

About

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.

Full description

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

Enrollment

14 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.