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JNJ-77474462

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 29, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04544826A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous DosesPHASE1 COMPLETED 24Oct 16, 2020Aug 5, 2021Sep 29, 20211 Australia
NCT04544813A Study of JNJ-77474462 in Healthy ParticipantsPHASE1 COMPLETED 78Oct 13, 2020May 30, 2021Jun 29, 20231 Australia
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to Week 16

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Number of Participants with Serious Adverse Events (SAEs)
Up to Week 16

A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
Up to Week 16

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Number of Participants with Clinically Significant Changes in Vital Signs
Up to Week 12

Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.

Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
Up to Week 12

Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported.

Number of Participants with Clinically Significant Changes in Hematology
Up to Week 12

Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count \[RBS\], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported.

Number of Participants with Clinically Significant Changes in Chemistry
Up to Week 12

Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.

Number of Participants with Clinically Significant Changes in Urinalysis
Up to Week 12

Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.

Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462
Up to Week 12

Cmax is the maximum observed plasma concentration.

Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462
Up to Week 12

AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.

Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of JNJ-77474462
Up to Week 12

AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.

Terminal Half-Life (T1/2) of JNJ-77474462
Up to Week 12

T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.

Absolute Subcutaneous (SC) Bioavailability (F%)
Up to Week 12

(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV \* 100 percent (%).

Secondary Endpoints
Maximum Observed Concentration (Cmax)
Up to Week 12
Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
Up to Week 12
Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])
Up to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Cohort 1: JNJ-77474462 (Low Dose) or PlaceboEXPERIMENTALParticipants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.
Cohort 2: JNJ-77474462 (Medium Dose) or PlaceboEXPERIMENTALParticipants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.
Cohort 3: JNJ-77474462 (High Dose) or PlaceboEXPERIMENTALParticipants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.
Cohort A: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 subcutaneously (SC).
Cohort B: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort C: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort D: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort E: JNJ-77474462 IV (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 intravenously (IV).
Cohort F: JNJ-77474462 SC (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort G: JNJ-77474462 SC (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort H: JNJ-77474462 IV (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 IV.
Cohort I: JNJ-77474462 IV (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 IV.
Cohort J: Anakinra SCACTIVE_COMPARATORParticipants will receive a SC injection of anakinra once daily for 3 days.
Interventions
NameTypeDescription
JNJ-77474462DRUGJNJ-77474462 will be administered as SC injection.
PlaceboDRUGMatching placebo to JNJ-77474462 will be administered as SC injection.
AnakinraDRUGParticipants will receive a SC injection of anakinra 100 mg once daily for 3 days.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must be of first to third generation Japanese descent * Participant must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1. Any abnormalities, must be consid...

Countries:Australia
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