Study of STLX-2012 in Healthy Volunteers

Stelexis BioSciences

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: STLX-2012; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07231744

STLX-2012-001

Details and patient eligibility

About

The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

STLX-2012

Experimental group

Description:

Single ascending doses of STLX-2012

Treatment:

Drug: STLX-2012

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo