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JNJ-26366821

Phase 1

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

JNJ-26366821 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2019

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

JNJ-26366821 clinical trials

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. It has been studied in a Phase 1 clinical trial in healthy adult participants, and its therapeutic indications have not been disclosed. It is not an approved medicine and remains in early clinical development.

Who makes JNJ-26366821?

JNJ-26366821 is being 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 conducted in the United States.

What phase is JNJ-26366821 in?

JNJ-26366821 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA for any indication.

What clinical trials is JNJ-26366821 in?

JNJ-26366821 has been evaluated in one clinical trial, NCT03990519, titled A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants. The Phase 1 study was completed, enrolled 33 healthy adult participants in the United States, and used a randomized, double-blind, controlled design.

Is JNJ-26366821 given as an injection?

JNJ-26366821 was administered as a single subcutaneous dose in its completed Phase 1 study, NCT03990519, which evaluated the compound in healthy participants. The trial enrolled 33 participants and was randomized, double-blind, and controlled.