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JNJ-54175446

Phase 1

Depressive Disorder, Major | Small molecule | Psychiatry |Johnson & Johnson|Trials Updated: Apr 27, 2025

JNJ-54175446 development status

Highest phase Phase 1
Registered trials 4 across 2 sponsors since Aug 2015

JNJ-54175446 target and mechanism

Molecular targetP2RX7
Target classAntagonist
ModalitySmall molecule

Also known as JNJ-54175446 (capsule)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

JNJ-54175446 clinical trials

JNJ-54175446 · 1 trial · 1 indication

Phase 1 1
NCT02902601A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive DisorderDepressive Disorder, Major
COMPLETED70 Analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder
Depressive Disorder, MajorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Up to Day 17

Secondary Endpoints

Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by HDRS17/IDS-C30 Rating Scale
Baseline, Day 4 and 10: 2 to 8 hours post dose, Day 17
Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by QIDS-SR16/QIDS-SR10 Rating Scale
Baseline, Day 3 and 10: 2 to 8 hours post dose, Day 17
Effect of JNJ-54175446 Versus Placebo on TSD-Induced Changes in Biomarker Profiles (interleukin [IL]-1 beta, cortisol)
Day 1 and 4: Predose, 2, 8 hours postdose, Day 10: Predose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group A: JNJ-54175446EXPERIMENTALParticipants will receive a loading dose of JNJ-54175446, 600 milligram (mg) on Day 1 followed by JNJ-54175446, 150 mg once daily until Day 10.
Group B: Placebo + JNJ-54175446EXPERIMENTALParticipants will receive placebo on Days 1 to 3 followed by a loading dose of JNJ-54175446, 600 mg on Day 4 followed by JNJ-54175446, 150 mg once daily until Day 10.
Group C: PlaceboPLACEBO_COMPARATORParticipants will receive placebo from Day 1 until Day 10.

Interventions

NameTypeDescription
JNJ-54175446, 600 mgDRUGParticipants will receive JNJ-54175446, 600 mg as an oral suspension.
JNJ-54175446, 150 mgDRUGParticipants will receive JNJ-54175446, 150 mg as an oral suspension.
PlaceboOTHERMatching placebo to JNJ-54175446
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Body mass index (BMI) must be between 18 and 32 kilogram per square meter (kg/m\^2) inclusive * Related to symptoms of depression: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV or V diagnostic criteria for Major Depressive Disorder \[...

Countries:GermanyNetherlands
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Frequently asked questions about JNJ-54175446

What is JNJ-54175446 used for?

JNJ-54175446 is an investigational small molecule being studied for the treatment of major depressive disorder. It has been evaluated in a Phase 1 clinical trial in participants with major depressive disorder. It is not approved for any indication and remains in clinical development.

What does JNJ-54175446 target?

JNJ-54175446 targets P2RX7, the P2X7 receptor. It acts as an antagonist at this target. By blocking P2RX7, the drug is designed to modulate neuroinflammatory signaling, a mechanism being explored in major depressive disorder.

Who is developing JNJ-54175446?

JNJ-54175446 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 trial of the drug in major depressive disorder.

What phase is JNJ-54175446 in?

JNJ-54175446 is in Phase 1 clinical development. It has completed one Phase 1 trial in major depressive disorder. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is JNJ-54175446 in?

JNJ-54175446 has been studied in one completed Phase 1 trial, NCT02902601, titled A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder. The trial enrolled 70 participants across Germany and the Netherlands and was randomized, double-blind, and placebo-controlled.

Is JNJ-54175446 the same as JNJ 54175446?

Yes, JNJ-54175446 and JNJ 54175446 refer to the same investigational drug. Other variations seen in study listings include JNJ-54175446 150 mg, JNJ-54175446 600 mg, and JNJ-54175446 (capsule), which describe dose strengths and the capsule formulation used in trials.