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New drug STLX-2012 tested in healthy people for first time

NCT ID NCT07231744

Knowledge-focused Sponsor: Stelexis BioSciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial will test the safety and tolerability of a single dose of STLX-2012 in 32 healthy adults aged 18-55. Participants will receive either the drug or a placebo, and researchers will monitor side effects and how the drug moves through the body. The study is not intended to treat any disease, but to gather essential safety data before testing in patients.

What this could mean

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

Active substance
STLX-2012

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

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 55 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: * Male or female participants aged 18-55 years old, inclusive, at Screening. * Body mass index of 18-32 kg/m\^2, inclusive * Healthy as determined by the investigator * Adequate hepatic and renal function * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures * Male participants and females of childbearing potential must agree to use an effective method of contraception for 30 days after the last dose of STLX-2012 Exclusion Criteria: * Pregnant or lactating female. * Positive urine drug screen or alcohol breath test * Neutropenia, defined as neutrophil count \<2.0 x 10\^9/L * History of allergic reaction requiring treatment or anaphylactic reactions to any therapeutic drug. * Previous treatment with an IL-1RAP monoclonal antibody * History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (excluding mild seasonal allergies)

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As listed by the trial registrant

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

Healthy participants

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

  • Nucleus Network Brisbane

    Brisbane, Queensland, 4006, Australia

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