Healthy ParticipantsPhase 1NCT07231744
Study of STLX-2012 in Healthy Volunteers
A Phase 1 study testing STLX-2012 in people with Healthy Participants, run by Stelexis BioSciences at 1 site in Australia.
Trial summary
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- STLX-2012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2026to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Nucleus Network Brisbane
Brisbane, Queensland, 4006
Nucleus Network Brisbane, 1800 243 733, brisbane@nucleusnetwork.com
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of STLX-2012 in Healthy Volunteers
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
- Conditions
- Healthy Participants
- Being tested
- STLX-2012, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STLX-2012Drug
STLX-2012 IV
PlaceboOther
Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| STLX-2012 | Experimental | Single ascending doses of STLX-2012 Receives: Drug: STLX-2012 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0
Measured: 56 days
Secondary outcomes (6)
Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC)
Measured: Day 1 - 29
Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax)
Measured: Day 1 - 29
Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax)
Measured: Day 1 - 29
Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½)
Measured: Day 1 - 29
Pharmacokinetics of STLX-2012: Clearance (CL)
Measured: Day 1 - 29
Pharmacokinetics of STLX-2012: Volume of distribution (Vd)
Measured: Day 1 - 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stelexis BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231744
- Sponsor's protocol ID
- STLX-2012-001
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans or process in place for sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of STLX-2012 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07231744
- Acronym / sponsor ID
- STLX-2012-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Stelexis BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STLX-2012 | Experimental | Drug: STLX-2012Single ascending doses of STLX-2012 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STLX-2012STLX-2012 IV | Drug | STLX-2012 |
| PlaceboPlacebo arm | Other | Placebo |
Primary outcome
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0
Time frame: 56 days
6 secondary outcomes
Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC)
Time frame: Day 1 - 29
Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax)
Time frame: Day 1 - 29
Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax)
Time frame: Day 1 - 29
Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½)
Time frame: Day 1 - 29
Pharmacokinetics of STLX-2012: Clearance (CL)
Time frame: Day 1 - 29
Pharmacokinetics of STLX-2012: Volume of distribution (Vd)
Time frame: Day 1 - 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. No plans or process in place for sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STLX-2012 in people with Healthy Participants, run by Stelexis BioSciences at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Office (508-543-6979, clinicaltrials@stelexis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0 (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.