ACTRN12621001571864已完成1 期
Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RLYB116 in Healthy Participants
IPC Research, LLC0 个研究点目标入组 89 人开始时间: 2021年11月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
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. Males and females age 18 to 55 years.
- •2. Able to provide written informed consent.
- •3. Body mass index (BMI) of 18.0 to 32.0 kg/m2.
- •4. Must have been vaccinated against N. meningitidis and S. pneumoniae with approved vaccine according to product label. All participants considered eligible for enrollment will be vaccinated according to the following:
- •a. Vaccination with Meningococcal Group A, C, W135, and Y conjugate vaccine (Menveo®) + Pneumococcal Polysaccharide Vaccine (Pneumovax® 23) at least 28 days prior to receiving the first dose of RLYB116.
- •b. Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116.
排除标准
- •1. Participants that smoke more than 10 cigarettes per week.
- •2. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus.
- •3. Pregnant or nursing.
- •4. Donation or loss of greater than 400 mL of blood within 56 days of study enrollment.
- •5. History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.
研究者
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