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JANX011

Phase 1

Autoimmune | Small molecule | Immunology |Janux Therapeutics, Inc.|Last Updated: Apr 23, 2026

Target and mechanism

Molecular targetCD19
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

JANX011 · 1 trial · 1 indication

Early Phase 1 1
NCT07291323Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.Autoimmune
RECRUITING60 Analytics
EARLY_PHASE1RECRUITING
Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.
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Study Endpoints

Primary Endpoints

Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.
Up to 85 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALDosage per cohort will increase to determine the maximum tolerable dose.

Interventions

NameTypeDescription
JANX011DRUGJANX011 is administered subcutaneously, one time.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and women, in the opinion of the PI or designee and as determined by physical examination, laboratory screening tests, and medical history. * Aged 18 to 65 years, with a body weight between 50 to 120 kg and a body mass index (BMI) between 18 to 32 kg/m2 (all inclus...

Countries:Australia
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Frequently asked questions about JANX011

What is JANX011 used for?

JANX011 is an investigational small molecule being developed for autoimmune conditions. It is currently in early Phase 1 clinical development, with a study enrolling healthy adult volunteers to assess its safety and tolerability. The drug is not yet approved and remains in clinical testing.

What does JANX011 target?

JANX011 targets CD19, a protein found on B cells. By targeting CD19, the drug is designed to modulate B-cell activity, which is relevant to autoimmune diseases. This mechanism is being evaluated in early clinical trials to understand its safety and tolerability.

Who makes JANX011?

JANX011 is being developed by Janux Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol JANX. The company is conducting a Phase 1 clinical trial of JANX011 in healthy volunteers to assess the drug's safety and tolerability.

What phase is JANX011 in?

JANX011 is in Phase 1 clinical development. The ongoing trial, NCT07291323, is an early Phase 1 study that is currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is JANX011 in?

JANX011 is being studied in one clinical trial, NCT07291323, titled 'Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.' This early Phase 1 study is recruiting 60 healthy volunteers in Australia and is not randomized or blinded.