NCT07231744尚未招募1 期
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
Stelexis BioSciences2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年10月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0
研究概览
简要总结
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
STLX-2012
Experimental
Single ascending doses of STLX-2012
干预措施: STLX-2012 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0
时间窗: 56 days
次要结局
- 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)
- Pharmacokinetics of STLX-2012: Volume of distribution (Vd)(Day 1 - 29)
研究者
研究点 (2)
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