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Not yet recruiting NCT07231744

Study of STLX-2012 in Healthy Volunteers

Phase I Interventional Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STLX-2012, Placebo.
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug STLX-2012
    STLX-2012 IV
  • Other Placebo
    Placebo arm

Primary outcome measures

  • Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0 [Time frame: 56 days]
Secondary outcome measures (6)
  • Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC) [Time frame: Day 1 - 29]
  • Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax) [Time frame: Day 1 - 29]
  • Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax) [Time frame: Day 1 - 29]
  • Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½) [Time frame: Day 1 - 29]
  • Pharmacokinetics of STLX-2012: Clearance (CL) [Time frame: Day 1 - 29]
  • Pharmacokinetics of STLX-2012: Volume of distribution (Vd) [Time frame: Day 1 - 29]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Australia · 1 center
  • Nucleus Network Brisbane — Brisbane

Identifiers

NCT: NCT07231744 · STLX-2012-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗