Study of STLX-2012 in Healthy Volunteers | NCT07231744

Studies
Study of STLX-2012 in Healthy Volunteers

NCT07231744

Sponsor

Stelexis BioSciences

Status

Not yet recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

32Estimated

Phase

Phase 1

Conditions

Healthy Participants

Interventions

STLX-2012
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2026Estimated

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Nov 13, 2025

First Submission Date that Met QC Criteria

Nov 14, 2025

First Posted Date

Nov 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STLX-2012	Experimental	Single ascending doses of STLX-2012	Drug: STLX-2012
Placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
STLX-2012	Drug	STLX-2012 IV	STLX-2012
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC)		Day 1 - 29
Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax)		Day 1 - 29

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Office	Contact	508-543-6979		clinicaltrials@stelexis.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Network Brisbane		Brisbane	Queensland	4006	Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

No plans or process in place for sharing IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided