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JNJ38224342

Phase 1

Seasonal Allergic Rhinitis | Small molecule | Respiratory |Johnson & Johnson|Last Updated: Sep 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment182

FDA Designations

No designations recorded

Clinical trial landscape

JNJ38224342 · 1 trial · 1 indication

Phase 1 1
NCT01054352A Single and Multiple Dose Study to Explore the Safety of JNJ-38224342 in Healthy Patients and Patients With Seasonal AllergiesSeasonal Allergic Rhinitis
COMPLETED182 Analytics
PHASE1COMPLETED
A Single and Multiple Dose Study to Explore the Safety of JNJ-38224342 in Healthy Patients and Patients With Seasonal Allergies
Seasonal Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess safety and pharmacokinetics of single and multiple oral ascending doses of JNJ-38224342 with and without food in healthy volunteers and patients with seasonal allergies as determined by occurrence of adverse events, lab test results, vital sign
from the time of the first dose to 7-11 days after the last dose administered

Secondary Endpoints

Evaluate the results of biomarker assessments performed during Parts 2 and 4 of the trial.
from 7-11 days post the last administered dose
Evaluate the effectiveness of treatment based on nasal symptoms for Part 4.
from 7-11 days post the last administered dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ38224342/placebo one of six (6) single ascending doses (25 100 300 600 1250 or 2000 mg) of JNJ 38224342 or matching placebo up to four (4) additional cohorts consisting of healthy male volunteers may be added
002EXPERIMENTALJNJ38224342/placebo multiple ascending oral doses (100 250 500 750 mg) of JNJ 38224342 or matching placebo administered for 14 consecutive days in healthy male or female volunteers.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
003EXPERIMENTALJNJ38224342 single oral 100mg dose of JNJ 38224342 as a solution versus a single oral dose of JNJ 38224342 as a capsule formulation with and without food in healthy male volunteers
004EXPERIMENTALJNJ38224342/placebo multiple oral doses of JNJ38224342 or matching placebo administered for up to 14 consecutive days in male and female volunteers number of days dosed and actual dose levels food requirements and regimens will be determined based on the data from Parts 1 2 and 3.

Interventions

NameTypeDescription
JNJ38224342DRUGmultiple ascending oral doses (100, 250, 500, 750 mg) of JNJ 38224342 or matching placebo, administered for 14 consecutive days in healthy male or female volunteers
JNJ38224342/placeboDRUGup to four (4) additional cohorts consisting of healthy male volunteers may be added
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Non-smokers * If male, willing to use an acceptable method of birth control for duration of study and for 90 days post study * Females must be post menopausal, surgically sterilized and cannot be pregnant or lactating (all parts of study) * Have a clinical history of allergic ...

Countries:Canada
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Frequently asked questions about JNJ38224342

What is JNJ38224342 used for?

JNJ38224342 is an investigational small molecule being studied for the treatment of Seasonal Allergic Rhinitis. It is in Phase 1 clinical development and has been evaluated in a completed clinical trial involving patients with seasonal allergies.

Who makes JNJ38224342?

JNJ38224342 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development for Seasonal Allergic Rhinitis.

What phase is JNJ38224342 in?

JNJ38224342 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and has completed one Phase 1 clinical trial for Seasonal Allergic Rhinitis.

What clinical trials is JNJ38224342 in?

JNJ38224342 has been studied in one completed clinical trial, NCT01054352, which explored the safety of single and multiple doses in healthy patients and patients with seasonal allergies. The trial enrolled 182 participants in Canada.

Is JNJ38224342 the same as JNJ-38224342?

Yes, JNJ38224342 and JNJ-38224342 refer to the same investigational drug. The clinical trial NCT01054352 uses the name JNJ-38224342, while the drug is also referred to as JNJ38224342 in development records.