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New autoimmune drug JANX011 enters first human safety trial

NCT ID NCT07291323

Knowledge-focused Sponsor: Janux Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests the safety of a new drug called JANX011 in 60 healthy adults. Researchers will give a single dose and monitor for side effects. The goal is to gather initial safety data before testing in people with autoimmune diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JANX011
What this could lead to
If safe, this could lead to a new treatment option for autoimmune diseases.
What could go wrong
This is an early Phase 1 study in healthy volunteers, not patients. It only tests safety and dosing, not effectiveness. Many early-stage drugs fail to show benefit later.
Why investors are watching

Janux Therapeutics is running a first-in-human trial of JANX011, a drug given to healthy volunteers to test its safety and how the body processes it. The trial is early, but it is the first look at whether JANX011 could work for autoimmune diseases, which matters for a small company whose value depends on its pipeline. A clear safety profile and signs of biological activity would give Janux a foundation to move the drug into patient studies.

If it works: A positive result could show that JANX011 is safe and behaves as expected in the body, supporting further development. That could strengthen Janux's pipeline and attract more attention from partners or investors.

If it fails: Early-stage trials often fail because the drug proves unsafe or does not work as hoped. A poor result or delay could set back Janux's plans for JANX011 and hurt confidence in the company.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 inclusive) at Screening. * Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures. Exclusion Criteria: * Recent surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study. * Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus 1 (HIV-1) or HIV-2 antibodies. * Positive test for tuberculosis (TB) or history of TB (including prior positive interferon gold test result). * Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to dosing on Day 1.

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Conditions

The condition(s) this trial relates to.

autoimmune disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CMAX

    RECRUITING

    Adelaide, South Australia, 5000, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.