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Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in Healthy Participants, and Atopic Participants With Mild to Mild-Persistent Asthma

Primary Purpose

Healthy, Asthma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

JNJ-43260295

Placebo

Nasal Allergen Challenge

About this trial

This is an interventional treatment trial for Healthy focused on measuring Healthy, Asthma, JNJ-43260295, Nasal Allergen Challenge

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants:

Participants must be non-smokers or non-regular smokers (1 to 2 cigarettes on the weekend as part of social gathering) for at least 3 months prior to Screening, according to the participant's self-reported medical history. Participants should be willing to (continue to) abstain from smoking from Screening until completion of the last study related activity
Participants must have a body mass index (BMI: weight in kilogram [kg] divided by the height in square meter [m^2]) of 18.0 to 30.0 kg/m^2, extremes included
Participants must have a normal 12-lead electrocardiogram (ECG) at Screening including normal sinus rhythm (heart rate between 40 and 100 beats per minute [bpm]); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than and equal to (<=) 450 milliseconds (ms); QRS interval lower than 120 ms; and PR interval <=220 ms
Participants must be healthy, with the exception of findings related to asthma and allergy in atopic mild to mild-Persistent asthmatic participants, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs (Systolic Blood Pressure [BP], Diastolic BP, pulse rate, respiratory rate, and body temperature), and the results of blood biochemistry and hematology tests performed at Screening
Participants must be willing/ able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

B. Atopic Mild to Mild-Persistent Asthmatic Participants:

Participants with Investigator-diagnosed mild to mild-persistent asthma based on the Guidelines for the Diagnosis and Management of Asthma
Participants having a well-established allergen profile (participants have been previously skin tested and, by history, have allergic responses to specific allergens)
Participants with forced expiratory volume in 1 second (FEV1) greater than (>) 70 percent (%) of predicted at Baseline

Exclusion Criteria:

A. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants:

Participants having a significant (by the assessment of the Investigator) nasal abnormality and/or has a history of nasal or sinus surgery within 12 months of enrollment
Participants having an upper or lower respiratory tract infection within 4 weeks of enrollment
Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 1 year, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
Participants with a known history of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or with a known history of hepatitis A, B, or C virus infection at study Screening
Female participants who are breastfeeding at Screening or having a positive urine pregnancy test at Screening

B. Atopic Mild to Mild-Persistent Asthmatic Participants:

Hospitalization or treatment in an emergency care facility for asthma during the last 3 years
Participants using nasal corticosteroids on a daily basis in the 4 weeks prior to enrollment
Participants who have received allergen immunotherapy in the last 2 years

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

JNJ-43260295 (Healthy Participants)

Placebo (Healthy Participants)

JNJ-43260295 (Asthmatic Participants)

Arm Description

Participants will receive a single nasal dose of JNJ-43260295, 6400 microgram, equally spread over the two nostrils.

Participants will receive a single nasal dose of placebo matching to JNJ-43260295.

Participants will participate in 3 consecutive treatment periods (Periods 1, 2, and 3). In Period 1, each participant will receive a single nasal dose of JNJ-43260295 without prior nasal allergen challenge. In Period 2, each participant will receive a single nasal dose of JNJ-43260295, preceded by a nasal allergen challenge approximately 15 hours prior to the dosing. In Period 3, each participant will receive single nasal allergen challenge without JNJ-43260295. There will be a washout period of at least 21 days between 3 consecutive treatment periods.

Outcomes

Primary Outcome Measures

Cytokine Levels in Nasal Lavage

Sixteen cytokines will be assessed: interferon alpha (IFN-alpha), IFN-beta, IFN-gamma, IFN-lambda, interleukin-1 alpha (IL-1 alpha), IL-4, IL-5, IL-6, IL 8, IL-10, IL-12p70, IL-13, IL-15, IL-17, IL-23, and tumor necrosis factor-alpha (TNF-alpha), using the 16-plex kit.

Gene Expression in Nasal Scrapings

Gene expression will be determined by analyzing total ribonucleic acid (RNA) by microarray chips.

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.

Full Information

NCT ID

NCT02243189

First Posted

September 16, 2014

Last Updated

March 22, 2016

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02243189

Brief Title

Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in Healthy Participants, and Atopic Participants With Mild to Mild-Persistent Asthma

Official Title

A Phase 1 Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in a Double-Blind, Randomized, Placebo-Controlled Setting in Healthy Subjects, and by an Open-Label Assessment in Atopic Subjects With Mild to Mild-Persistent Asthma With and Without Nasal Allergen Challenge Prior to Dosing

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

Under enrollment and IP supply expiring.

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate the cytokine levels in nasal lavage and gene expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which there is wheezing and difficulty in breathing) participants with and without nasal allergen challenge prior to dosing.

Detailed Description

This study consists of 2 parts. In first part, healthy adult participants will receive a single nasal dose of JNJ-43260295 or placebo in a double blind (both the participant and investigator do not know whether participant is assigned to receive study medication or placebo), randomized (study medication or placebo assigned to participants by chance), and placebo-controlled (study in which the experimental treatment or procedure is compared to a placebo) setting. In second part, which will be open label (participants and investigators are aware about the treatment, participants are receiving), atopic participants with mild to mild-persistent asthma will participate in 3 consecutive treatment periods (Period 1, 2, and 3). In Period 1, each participant will receive a single nasal dose of JNJ-43260295 without prior nasal allergen challenge. In Period 2, each participant will receive a single nasal dose of JNJ-43260295, preceded by a nasal allergen challenge approximately 15 hours prior to the JNJ-43260295 dosing. In Period 3, each participant will receive single nasal allergen challenge without JNJ-43260295. There will be a washout period of at least 21 days between 3 consecutive treatment periods. Cytokine levels in nasal lavage and gene expression in nasal scraping will be primarily evaluated during all treatment periods. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Asthma

Keywords

Healthy, Asthma, JNJ-43260295, Nasal Allergen Challenge

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JNJ-43260295 (Healthy Participants)

Arm Type

Experimental

Arm Description

Participants will receive a single nasal dose of JNJ-43260295, 6400 microgram, equally spread over the two nostrils.

Arm Title

Placebo (Healthy Participants)

Arm Type

Placebo Comparator

Arm Description

Participants will receive a single nasal dose of placebo matching to JNJ-43260295.

Arm Title

JNJ-43260295 (Asthmatic Participants)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

JNJ-43260295

Intervention Description

A single nasal dose of JNJ-43260295, 6400 microgram, will be given.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

A single nasal dose of placebo matching to JNJ-43260295 will be given.

Intervention Type

Drug

Intervention Name(s)

Nasal Allergen Challenge

Intervention Description

Participants will be challenged by the nasal route with an appropriate allergen based on skin test reactivity.

Primary Outcome Measure Information:

Title

Cytokine Levels in Nasal Lavage

Description

Time Frame

Up to 48 hours post dose

Title

Gene Expression in Nasal Scrapings

Description

Gene expression will be determined by analyzing total ribonucleic acid (RNA) by microarray chips.

Time Frame

Up to 48 hours post dose

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Description

Time Frame

AEs: Baseline up to 8 days after the last dose of study drug; SAEs: Baseline up to 30 days after the last dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants: Participants must be non-smokers or non-regular smokers (1 to 2 cigarettes on the weekend as part of social gathering) for at least 3 months prior to Screening, according to the participant's self-reported medical history. Participants should be willing to (continue to) abstain from smoking from Screening until completion of the last study related activity Participants must have a body mass index (BMI: weight in kilogram [kg] divided by the height in square meter [m^2]) of 18.0 to 30.0 kg/m^2, extremes included Participants must have a normal 12-lead electrocardiogram (ECG) at Screening including normal sinus rhythm (heart rate between 40 and 100 beats per minute [bpm]); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than and equal to (<=) 450 milliseconds (ms); QRS interval lower than 120 ms; and PR interval <=220 ms Participants must be healthy, with the exception of findings related to asthma and allergy in atopic mild to mild-Persistent asthmatic participants, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs (Systolic Blood Pressure [BP], Diastolic BP, pulse rate, respiratory rate, and body temperature), and the results of blood biochemistry and hematology tests performed at Screening Participants must be willing/ able to adhere to the prohibitions and restrictions specified in the protocol and study procedures B. Atopic Mild to Mild-Persistent Asthmatic Participants: Participants with Investigator-diagnosed mild to mild-persistent asthma based on the Guidelines for the Diagnosis and Management of Asthma Participants having a well-established allergen profile (participants have been previously skin tested and, by history, have allergic responses to specific allergens) Participants with forced expiratory volume in 1 second (FEV1) greater than (>) 70 percent (%) of predicted at Baseline Exclusion Criteria: A. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants: Participants having a significant (by the assessment of the Investigator) nasal abnormality and/or has a history of nasal or sinus surgery within 12 months of enrollment Participants having an upper or lower respiratory tract infection within 4 weeks of enrollment Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 1 year, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures Participants with a known history of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or with a known history of hepatitis A, B, or C virus infection at study Screening Female participants who are breastfeeding at Screening or having a positive urine pregnancy test at Screening B. Atopic Mild to Mild-Persistent Asthmatic Participants: Hospitalization or treatment in an emergency care facility for asthma during the last 3 years Participants using nasal corticosteroids on a daily basis in the 4 weeks prior to enrollment Participants who have received allergen immunotherapy in the last 2 years

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

City

Charlottesville

State/Province

Virginia

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in Healthy Participants, and Atopic Participants With Mild to Mild-Persistent Asthma

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