Study of STLX-2012 in Healthy Volunteers
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
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2026
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
Study Completion
Last participant's last visit for all outcomes
February 1, 2027
April 22, 2026
April 1, 2026
4 months
November 13, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0
56 days
Secondary Outcomes (6)
Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC)
Day 1 - 29
Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax)
Day 1 - 29
Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax)
Day 1 - 29
Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½)
Day 1 - 29
Pharmacokinetics of STLX-2012: Clearance (CL)
Day 1 - 29
- +1 more secondary outcomes
Study Arms (2)
STLX-2012
EXPERIMENTALSingle ascending doses of STLX-2012
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nucleus Network Brisbane
Brisbane, Queensland, 4006, Australia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 17, 2025
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
No plans or process in place for sharing IPD