Study of STLX-2012 in Healthy Volunteers

April 21, 2026 updated by: Stelexis BioSciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo arm
Experimental: STLX-2012
Single ascending doses of STLX-2012
Drug: STLX-2012
STLX-2012 IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0
Time Frame: 56 days
56 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC)
Time Frame: Day 1 - 29
Day 1 - 29
Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax)
Time Frame: Day 1 - 29
Day 1 - 29
Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax)
Time Frame: Day 1 - 29
Day 1 - 29
Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½)
Time Frame: Day 1 - 29
Day 1 - 29
Pharmacokinetics of STLX-2012: Clearance (CL)
Time Frame: Day 1 - 29
Day 1 - 29
Pharmacokinetics of STLX-2012: Volume of distribution (Vd)
Time Frame: Day 1 - 29
Day 1 - 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stelexis BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STLX-2012-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans or process in place for sharing IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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