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JNJ-70099731

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Apr 27, 2025

JNJ-70099731 target and mechanism

ModalitySmall molecule

Also known as [18F]-JNJ-70099731

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

JNJ-70099731 clinical trials

JNJ-70099731 · 1 trial · 1 indication

Phase 1 1
NCT04911543A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male ParticipantsHealthy
COMPLETED13 Analytics
PHASE1COMPLETED
A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants
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Study Endpoints

Primary Endpoints

Part A: Normalized Cumulative Activity and Residence Time
Day 1

Normalized cumulative activity and residence time will be reported.

Part A: Radiation Absorbed Doses for 25 Organs and the Effective Dose (ED) of [18F]-JNJ-70099731
Day 1

The tissue radioactivity will be measured per organ for up to 5 hours after injection of \[18F\]-JNJ-70099731 and corrected for attenuation by computed tomography (CT) transmission scans using positron emission tomography (PET)/CT. These measurements will be used to estimate effective radiation dose per organ and total body.

Part B: Input Function Values kilobecquerel (kBq/cc) for Various Time Points and Tracer Kinetics in Selected Brain Structures
Day 1

The Distribution of \[18F\]JNJ-70099731 in brain will be measured by PET/CT scans obtained from the time of injection along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution.

Part C: Participant Variability in PET Distribution Parameters Over Time
Day 1

Participant variability in PET distribution parameters over time will be compared between the paired PET scans to assess test-retest variability in the regional brain kinetics and binding properties of \[18F\]-JNJ-70099731.

Secondary Endpoints

Part A, B and C: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Part A and B: Up to Week 5; Part C: Up to Week 6
Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Vital Signs Abnormalities
Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6
Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Clinical Labs (Chemistry, Hematology, Urinalysis) Abnormalities
Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: [18F]-JNJ-70099731EXPERIMENTALParticipants will receive an intravenous (IV) bolus injection of \[18F\]-JNJ-70099731 on Day 1 of Part A to investigate the total body bio-distribution and measure the radiation dosimetry of \[18F\]-JNJ-70099731.
Part B: [18F]-JNJ-70099731EXPERIMENTALParticipants will receive an IV bolus injection of \[18F\]-JNJ-70099731 on Day 1 of Part B to measure the uptake, distribution, and clearance of \[18F\]-JNJ-70099731 and to model the tissue specific kinetics of \[18F\]-JNJ-70099731 in the human brain with the appropriate arterial input function.
Part C: [18F]-JNJ-70099731EXPERIMENTALParticipants will receive an IV bolus injection of \[18F\]-JNJ-70099731 on Day 1 of each period of Part C to determine the test-retest variability in the regional brain kinetics and binding properties of \[18F\]-JNJ-70099731.

Interventions

NameTypeDescription
[18F]-JNJ-70099731DRUG\[18F\]JNJ-70099731 injection will be administered intravenously.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m\^2) inclusive * Participant must be healthy on the basis of physical and neurological examination, medical history, clinical laboratory tests, vital sign (VS), and 12-lead electrocardiogram (ECG) performed...

Countries:Belgium
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Frequently asked questions about JNJ-70099731

What is JNJ-70099731?

JNJ-70099731 is an investigational small molecule developed by Johnson & Johnson. It is studied as a positron emission tomography (PET) ligand, labeled with fluorine-18 as [18F]-JNJ-70099731, to image brain kinetics. It has completed a Phase 1 study in healthy male participants in Belgium.

Is JNJ-70099731 the same as [18F]-JNJ-70099731?

Yes. JNJ-70099731 and [18F]-JNJ-70099731 refer to the same compound. The bracketed name reflects the fluorine-18 radiolabel used for PET imaging, while JNJ-70099731 is the base drug identifier used by Johnson & Johnson.

Who makes JNJ-70099731?

JNJ-70099731 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is an investigational small molecule studied as a fluorine-18 labeled PET ligand.

What phase is JNJ-70099731 in?

JNJ-70099731 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.

What clinical trials is JNJ-70099731 in?

JNJ-70099731 has been evaluated in one completed Phase 1 trial, NCT04911543, titled a study to investigate the regional brain kinetics of the PET ligand [18F]-JNJ-70099731 in healthy male participants. The trial enrolled 13 participants in Belgium and included a controlled design.

What is JNJ-70099731 used for?

JNJ-70099731 is being studied as a PET imaging ligand to investigate regional brain kinetics. Its clinical development has involved healthy male volunteers rather than a specific patient population, and no therapeutic indication has been disclosed.