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JNJ-61178104

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Jan 23, 2017

JNJ-61178104 target and mechanism

ModalitySmall molecule

Also known as JNJ-61178104 Intravenous

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

JNJ-61178104 clinical trials

JNJ-61178104 · 1 trial · 1 indication

Phase 1 1
NCT02758392A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy ParticipantsHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability
Day 113

Secondary Endpoints

Serum Concentration of JNJ-61178104
Up to Day 113
JNJ-61178104 Antibodies Concentration
Up to Day 113
Cytokine Concentrations
Predose, Up to Day 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose 1: JNJ-61178104 OR Placebo IVEXPERIMENTALParticipants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1.
Dose 2: JNJ-61178104 OR Placebo IVEXPERIMENTALParticipants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1.
Dose 3: JNJ-61178104 OR Placebo IVEXPERIMENTALParticipants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1.
Dose 4: JNJ-61178104 OR Placebo IVEXPERIMENTALParticipants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1.
Dose 5: JNJ-61178104 OR Placebo IVEXPERIMENTALParticipants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1.
Dose 6: JNJ-61178104 OR Placebo SCEXPERIMENTALParticipants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1.

Interventions

NameTypeDescription
JNJ-61178104 IntravenousDRUGParticipants will receive JNJ-61178104 Intravenously on Day 1.
JNJ-61178104 SubcutaneousDRUGParticipants will receive JNJ-61178104 Subcutaneously on Day 1.
PlaceboDRUGParticipants will receive placebo on Day 1.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study * Participant must have a body weight in the range of 50 Kilogram (kg) to 100 kg, inclusiv...

Countries:Belgium
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Frequently asked questions about JNJ-61178104

What is JNJ-61178104?

JNJ-61178104 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult participants. No approved indication has been disclosed for this asset, and it remains in clinical development rather than on the market.

Who makes JNJ-61178104?

JNJ-61178104 is 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 in healthy volunteers. No partner or licensee for the program has been disclosed.

What phase is JNJ-61178104 in?

JNJ-61178104 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed for the compound. It is an investigational agent and has not been approved for any indication.

What clinical trials is JNJ-61178104 in?

JNJ-61178104 has been evaluated in one clinical trial, NCT02758392, titled A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants. That Phase 1 study is completed, enrolled 54 participants, was randomized, double blind, and controlled, and was conducted in Belgium.

Is JNJ-61178104 the same as JNJ-61178104 Intravenous?

Yes. JNJ-61178104 Intravenous is another name used for JNJ-61178104, so searches for either term refer to the same investigational compound from Johnson & Johnson. The intravenous form is the version studied in the completed Phase 1 trial in healthy participants.

What was studied in the JNJ-61178104 Phase 1 trial?

The Phase 1 trial NCT02758392 evaluated the safety and tolerability of JNJ-61178104 in healthy participants. It enrolled 54 adults aged 18 years and older of any sex, used a randomized, double blind, controlled design, and was conducted in Belgium. The study is completed.