HealthyPhase 1NCT02243189
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
A Phase 1 study testing JNJ-43260295 and Nasal Allergen Challenge in people with Healthy and Asthma, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- JNJ-43260295 and Nasal Allergen Challenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- JNJ-43260295, Placebo, Nasal Allergen Challenge
- Keywords
- Healthy, Asthma, JNJ-43260295, Nasal Allergen Challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-43260295Drug
A single nasal dose of JNJ-43260295, 6400 microgram, will be given.
PlaceboDrug
A single nasal dose of placebo matching to JNJ-43260295 will be given.
Nasal Allergen ChallengeDrug
Participants will be challenged by the nasal route with an appropriate allergen based on skin test reactivity.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-43260295 (Healthy Participants) | Experimental | Participants will receive a single nasal dose of JNJ-43260295, 6400 microgram, equally spread over the two nostrils. Receives: Drug: JNJ-43260295 |
| Placebo (Healthy Participants) | Placebo comparator | Participants will receive a single nasal dose of placebo matching to JNJ-43260295. Receives: 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. Receives: Drug: JNJ-43260295; Drug: Nasal Allergen Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 48 hours post dose
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Under enrollment and IP supply expiring.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243189
- Sponsor's protocol ID
- CR105491
- Other IDs
- 43260295HRV1003
- Status last verified
- Mar 2016
- First submitted
- 16 Sep 2014
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02243189
- Acronym / sponsor ID
- CR105491
- Keywords
- Healthy, Asthma, JNJ-43260295, Nasal Allergen Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Under enrollment and IP supply expiring.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JNJ-43260295 (Healthy Participants) | Experimental | Drug: JNJ-43260295Participants will receive a single nasal dose of JNJ-43260295, 6400 microgram, equally spread over the two nostrils. |
| Placebo (Healthy Participants) | Placebo comparator | Drug: PlaceboParticipants will receive a single nasal dose of placebo matching to JNJ-43260295. |
| JNJ-43260295 (Asthmatic Participants) | Experimental | Drug: JNJ-43260295, Drug: Nasal Allergen ChallengeParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-43260295A single nasal dose of JNJ-43260295, 6400 microgram, will be given. | Drug | JNJ-43260295 (Asthmatic Participants), JNJ-43260295 (Healthy Participants) |
| PlaceboA single nasal dose of placebo matching to JNJ-43260295 will be given. | Drug | Placebo (Healthy Participants) |
| Nasal Allergen ChallengeParticipants will be challenged by the nasal route with an appropriate allergen based on skin test reactivity. | Drug | JNJ-43260295 (Asthmatic Participants) |
Primary outcome
Cytokine Levels in Nasal Lavage
Time frame: Up to 48 hours post dose
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
Time frame: Up to 48 hours post dose
Gene expression will be determined by analyzing total ribonucleic acid (RNA) by microarray chips.
1 secondary outcome
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
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
Results and safety
The study was stopped early (reason given: Under enrollment and IP supply expiring.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-43260295 and Nasal Allergen Challenge in people with Healthy and Asthma, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Under enrollment and IP supply expiring.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine Levels in Nasal Lavage (time frame: Up to 48 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.