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

NCT02243189 | Terminated Phase 1

• 2 other identifiers: CR10549143260295HRV1003
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Asthma

Keywords

Healthy; Asthma; JNJ-43260295; Nasal Allergen Challenge

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 48 hours post dose

• Gene Expression in Nasal Scrapings

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

  Up to 48 hours post dose

Secondary Outcomes (1)

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

  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

Study Arms (3)

JNJ-43260295 (Healthy Participants)

EXPERIMENTAL

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

Drug: JNJ-43260295

Placebo (Healthy Participants)

PLACEBO COMPARATOR

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

Drug: Placebo

JNJ-43260295 (Asthmatic Participants)

EXPERIMENTAL

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.

Drug: JNJ-43260295; Drug: Nasal Allergen Challenge

Interventions

JNJ-43260295 DRUG

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

JNJ-43260295 (Asthmatic Participants); JNJ-43260295 (Healthy Participants)

Placebo DRUG

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

Placebo (Healthy Participants)

Nasal Allergen Challenge DRUG

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

JNJ-43260295 (Asthmatic Participants)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Charlottesville, Virginia, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

US (1)