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JNJ-54452840

Phase 2

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Mar 23, 2015

JNJ-54452840 development status

Highest phase Phase 2 (NCT01798745)
Phase scored for JNJPhase 1
Registered trials 3 across 1 sponsor since Feb 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

JNJ-54452840 clinical trials

JNJ-54452840 · 1 trial · 1 indication

Phase 1 1
NCT01809353To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian ParticipantsHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum concentrations of JNJ-54452840
Up to Day 2

Serum concentrations of JNJ-54452840 will be used to determine pharmacokinetic parameters for JNJ-54452840

Secondary Endpoints

Number of participants with an adverse event as a measure of safety
Up to Day 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group A: JNJ-54452840 20 mgEXPERIMENTALEach participant will receive 20 mg of JNJ-54452840 as a single intravenous dose.
Group A: JNJ-54452840 80 mgEXPERIMENTALEach participant will receive 80 mg of JNJ-54452840 as a single intravenous dose.
Group A: JNJ-54452840 240 mgEXPERIMENTALEach participant will receive 240 mg of JNJ-54452840 as a single intravenous dose.
Group A: PlaceboPLACEBO_COMPARATOREach participant will receive matching placebo as a single intravenous dose.
Group B: JNJ-54452840 20 mgEXPERIMENTALEach participant will receive 20 mg of JNJ-54452840 as a single intravenous dose.
Group B: JNJ-54452840 80 mgEXPERIMENTALEach participant will receive 80 mg of JNJ-54452840 as a single intravenous dose.
Group B: JNJ-54452840 240 mgEXPERIMENTALEach participant will receive 240 mg of JNJ-54452840 as a single intravenous dose.
Group B: PlaceboPLACEBO_COMPARATOREach participant will receive matching placebo as a single intravenous dose.

Interventions

NameTypeDescription
JNJ-54452840DRUGSingle intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg
PlaceboOTHERSingle matching intravenous dose
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Eligibility Criteria

Age Range20 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be a healthy male with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments - Must be Japanese or Caucasian * Japanese participants must have been born in Japan, have resided outs...

Countries:United States
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Frequently asked questions about JNJ-54452840

What is JNJ-54452840?

JNJ-54452840 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy volunteers rather than in patients with a specific disease. No therapeutic indication for the compound has been disclosed.

Who makes JNJ-54452840?

JNJ-54452840 is made 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 the United States.

What phase is JNJ-54452840 in?

JNJ-54452840 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA for any use.

What clinical trials is JNJ-54452840 in?

JNJ-54452840 has been evaluated in one completed Phase 1 trial, NCT01809353, titled "To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants." The study enrolled 32 healthy male volunteers in the United States.

How was the JNJ-54452840 Phase 1 trial designed?

The Phase 1 trial NCT01809353 was a randomized, double-blind, placebo-controlled study of single doses of JNJ-54452840. It enrolled 32 healthy male participants aged 20 years and older in the United States and assessed pharmacokinetics and safety in Japanese and Caucasian volunteers. The trial is completed.