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JNJ-26528398

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Jun 24, 2013

JNJ-26528398 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

JNJ-26528398 clinical trials

JNJ-26528398 · 1 trial · 1 indication

Phase 1 1
NCT01520142Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male ParticipantsHealthy Participants
COMPLETED19 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

The TNF-α concentrations in plasma (Part 2)
Days 7-8

Secondary Endpoints

Other markers of inflammation in blood (Part 2)
Days 7-8
Profile of Mood States (POMS) (Part 2)
Days 1 and 7
Incidence of adverse events amongst participants (Parts 1 and 2)
Days -1 to 10 and Day 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
JNJ-26528398DRUGIn Study Part 1, the participant will receive an oral solution of JNJ-26528398 3 mg once daily for 7 days. The same dosing regimen is planned for Part 2, but may be adjusted (lower dose and/or fewer dosing days) based on the data from Part 1.
PlaceboDRUGIn both Study Part 1 and Part 2, the participant will receive an oral solution of matching placebo once daily for up to 7 days.
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Eligibility Criteria

Age Range18 Years to 35 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Nonsmoker * Be in good health on the basis of physical examination, medical history, and electrocardiogram (ECG) * Must have good exercise tolerance * Have a body mass index of 18-29 kg/m2, inclusive, and body weight between 60 and 85 kg, inclusive * Have a history of consiste...

Countries:Belgium
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Frequently asked questions about JNJ-26528398

What is JNJ-26528398?

JNJ-26528398 is an investigational small molecule drug developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy male participants. No approved indication has been announced for JNJ-26528398, and it remains in early clinical development.

Who makes JNJ-26528398?

JNJ-26528398 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound conducted in Belgium.

What phase is JNJ-26528398 in?

JNJ-26528398 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials of JNJ-26528398 are currently listed.

What clinical trials is JNJ-26528398 in?

JNJ-26528398 has been evaluated in one completed Phase 1 trial, NCT01520142, titled Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants. The trial enrolled 19 healthy male volunteers aged 18 years and older in Belgium and was randomized, double-blind, and placebo-controlled.

What was studied in the JNJ-26528398 Phase 1 trial?

The Phase 1 trial NCT01520142 assessed the safety, tolerability, and pharmacodynamic activity of JNJ-26528398 in healthy male participants. It enrolled 19 participants in Belgium and used a randomized, double-blind, placebo-controlled design. The study has been completed.