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Not yet recruiting Phase 1 NCT07231744

Study of STLX-2012 in Healthy Volunteers

Phase 1 – testing safety in a small group of people
Conditions: Healthy Participants

Sponsor: Stelexis BioSciences

trial.available_in: БГ
Overview
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
Who can participate
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)
Interventions
STLX-2012
DRUG
Placebo
OTHER
Locations 1
Australia (1)
Nucleus Network Brisbane
Brisbane , Queensland
Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
01.10.2026
Completion date
01.02.2027
Registry ID
NCT07231744
Source
clinicaltrials.gov
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