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NCT Number: NCT07231744

Study 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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

STLX-2012

Drug

STLX-2012 IV

Placebo

Other

Placebo arm

Primary outcomes

  1. Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0

    Time frame: 56 days

Secondary outcomes

  1. Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC)

    Time frame: Day 1 - 29

  2. Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax)

    Time frame: Day 1 - 29

  3. Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax)

    Time frame: Day 1 - 29

  4. Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½)

    Time frame: Day 1 - 29

  5. Pharmacokinetics of STLX-2012: Clearance (CL)

    Time frame: Day 1 - 29

  6. Pharmacokinetics of STLX-2012: Volume of distribution (Vd)

    Time frame: Day 1 - 29

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Office

CONTACT

[email protected]

508-543-6979

Sponsors and collaborators

Lead sponsor

Stelexis BioSciences

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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