ACTRN12626000876392招募中1 期
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Proof-of-Mechanism of VIAL-IL13xTSLP in Healthy Adult Volunteers
Vial Australia Pty Ltd0 个研究点目标入组 24 人开始时间: 2026年3月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •All Participants:
- •Body Mass Index (BMI) 18–32 kg/m²
- •Considered healthy per investigator assessment
- •Adequate contraception (females must use effective contraception, be postmenopausal, surgically sterile, or abstinent; males must use barrier contraception or be abstinent and refrain from sperm donation)
排除标准
- •Clinically significant medical history or concomitant medications
- •Active/latent TB
- •Malignancy within 5 years
- •Autoimmune disorders
- •HIV/HBV/HCV positivity
- •Elevated liver/renal markers
- •Eosinophilic disease
- •Substance/alcohol use disorder
- •Prior IL-13/TSLP biologics
- •Live vaccine within 28 days.
研究组 & 干预措施
Required 1a Cohorts: VIAL-IL13xTSLP administered as a single open-label, non-randomised intravenous infusion to healthy volunteers at five ascending dose levels (15, 50, 150, 400, and 800 mg); no placebo is administered.
干预措施: Required 1a Cohorts: VIAL-IL13xTSLP administered as a single open-label, non-randomised intravenous infusion to healthy volunteers at five ascending dose levels (15, 50, 150, 400, and 800 mg); no placebo is administered.
研究者
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