Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Healthy Participants
Спонсор: Stelexis BioSciences
Налично на:
БГ
Обобщение
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
Кой може да участва
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)