The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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)
Primary outcome measure(s)
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0 — 56 days
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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