Status:
TERMINATED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 atop...
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 kn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02243189
Start Date
October 1 2014
End Date
December 1 2014
Last Update
March 23 2016
Active Locations (1)
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1
Charlottesville, Virginia, United States