Study of STLX-2012 in Healthy Volunteers

NCT ID: NCT07231744

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-02-28

Brief Summary

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The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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STLX-2012

Single ascending doses of STLX-2012

Group Type EXPERIMENTAL

STLX-2012

Intervention Type DRUG

STLX-2012 IV

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo arm

Interventions

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STLX-2012

STLX-2012 IV

Intervention Type DRUG

Placebo

Placebo arm

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stelexis BioSciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nucleus Network Brisbane

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

Central Contacts

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Clinical Trials Office

Role: CONTACT

508-543-6979

Facility Contacts

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Nucleus Network Brisbane

Role: primary

1800 243 733

Other Identifiers

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STLX-2012-001

Identifier Type: -

Identifier Source: org_study_id

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