ACTRN12621001235897已完成1 期
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of Nebulized IN-006 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Male and female, age 18-55 years, inclusive.
- •2.Non-smoker or smokes on average less than or equal to 10 cigarettes per week
- •3.Woman participants must be non-pregnant and either surgically sterile, use an acceptable contraceptive method, or be post-menopausal
- •4.Male participants must be surgically sterile, abstinent, or if engaged in sexual relations with a WOCBP, the partner must be surgically sterile or using an acceptable contraceptive method
- •5.Negative SARS-CoV-2 RT-PCR nasal swab during screening period
排除标准
- •1.Known or suspected symptomatic viral infection within 14 days of dosing initiation.
- •2.Signs of active pulmonary infection or pulmonary inflammatory conditions within 14 days of dosing.
- •3.History of hypersensitivity or allergies to a biologic drug or a constituent of the study drug or placebo.
- •4.History of previous administration of a monoclonal antibody or any inhaled biologic.
- •5.History of vaccination against SARS-CoV-2.
- •6.History of atopy or airway hyperresponsiveness.
研究者
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