Recent Updates
Recently added Catalysts

JNJ-61178104

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 23, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about JNJ-61178104

What is JNJ-61178104 used for?

JNJ-61178104 is an investigational small molecule being studied in healthy participants. It is being evaluated for safety and tolerability in a Phase 1 clinical trial. The drug is not approved for any medical condition and is still in clinical development.

Who makes JNJ-61178104?

JNJ-61178104 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in healthy participants.

What phase is JNJ-61178104 in?

JNJ-61178104 is in Phase 1 clinical development. This phase focuses on evaluating the safety and tolerability of the drug in healthy participants. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is JNJ-61178104 in?

JNJ-61178104 has one completed clinical trial, NCT02758392, which was a Phase 1 study in healthy participants. The trial was conducted in Belgium and enrolled 54 participants. It was a randomized, double-blind, controlled study to evaluate the safety and tolerability of the drug.

Is JNJ-61178104 FDA approved?

JNJ-61178104 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT02758392, was a Phase 1 study in healthy participants to evaluate safety and tolerability, but the drug has not received regulatory approval.