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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Active; Drug: Placebo

• Registration Number: NCT01316315
• Lead Sponsor: Nivalis Therapeutics, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Results First Submitted: 2014-01-28
• Results First Submitted QC: 2014-01-28
• Results First Posted: 2014-03-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-17
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	Active	N6022 - 5 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing	8 hours	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.
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.	10 Weeks	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.

Trial Locations

Locations (2)

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Duke Asthma, Allergy and Airway Center; 🇺🇸 Durham, North Carolina, United States