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JNJ-26366821

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 27, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-26366821 · 1 trial · 1 indication

Phase 1 1
NCT03990519A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy ParticipantsHealthy
COMPLETED33 Analytics
PHASE1COMPLETED
A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Up to Day 30

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.

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) of JNJ-26366821
Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30
Area Under the Plasma Concentration Versus Time Curve from Time 0 to Time of the Last Measurable Concentration AUC0-Last of JNJ-26366821
Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30
Apparent Elimination Half-Life (t1/2) of JNJ-26366821
Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort1: JNJ-2636682/PlaceboEXPERIMENTALParticipants will receive single dose of JNJ-26366821 or placebo on Day 1.
Cohort 2: JNJ-26366821/PlaceboEXPERIMENTALParticipants will receive single dose of JNJ-26366821 or placebo on Day 1.
Cohort 3: JNJ-26366821/PlaceboEXPERIMENTALParticipants will receive single dose of JNJ-26366821 or placebo. The dose of JNJ-26366821 will be selected based on the safety, pharmacodynamics, and pharmacokinetics data from the previous Cohorts 1 and 2.

Interventions

NameTypeDescription
JNJ-26366821DRUGParticipants will receive sterile solution of JNJ-26366821 subcutaneously (SC).
PlaceboDRUGParticipants will receive sodium chloride injection as placebo on Day 1.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overall good health, on the basis of full physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening * Body weight 50 - 100 kilogram (kg), body mass index (BMI) 18 - 30 kilogram per meter square (kg/m\^2), inclusive at screen...

Countries:United States
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Frequently asked questions about JNJ-26366821

What is JNJ-26366821?

JNJ-26366821 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other.

What is JNJ-26366821 used for?

JNJ-26366821 is being studied for use in healthy participants. It is an investigational small molecule in Phase 1 clinical development. The drug has not been approved for any indication and remains in clinical testing.

Who makes JNJ-26366821?

JNJ-26366821 is developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The drug is an investigational small molecule currently in Phase 1 clinical development.

What phase is JNJ-26366821 in?

JNJ-26366821 is in Phase 1 clinical development. It is an investigational small molecule being studied in healthy participants. The drug is not approved and remains in clinical testing.

What clinical trials is JNJ-26366821 in?

JNJ-26366821 has been studied in a Phase 1 clinical trial with the identifier NCT03990519. This trial, titled "A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants," was completed in the United States and enrolled 33 participants.

Is JNJ-26366821 the same as any other drug?

JNJ-26366821 is an investigational small molecule developed by Johnson & Johnson. It is currently in Phase 1 clinical development and has been studied in healthy participants. No alternative names for this drug have been reported.