Study of STLX-2012 in Healthy Volunteers

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07231744

Enrollment

Registered

2025-11-17

Start date

2026-10-01

Completion date

2027-02-01

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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.

Interventions

DRUGSTLX-2012

STLX-2012 IV

OTHERPlacebo

Placebo arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	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
Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax)	Day 1 - 29
Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½)	Day 1 - 29
Pharmacokinetics of STLX-2012: Clearance (CL)	Day 1 - 29
Pharmacokinetics of STLX-2012: Volume of distribution (Vd)	Day 1 - 29

Countries

Australia

Contacts

CONTACTClinical Trials Office

clinicaltrials@stelexis.com508-543-6979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026