NCT06797375进行中（未招募）1 期
Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RLYB116 in Healthy Participants
Rallybio1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年4月14日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of participants with treatment related adverse events as defined by CTCAE 5.0.
研究概览
简要总结
This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 and female participants, 18 to 55 years of age.
- •Able to provide written informed consent.
- •Body mass index (BMI) of 18.0 to 32.0 kg/m
- •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 or willing to receive vaccination according to the following:
- •Vaccination with Meningococcal Group A, C, W135, and Y conjugate vaccine (Menveo® or an acceptable alternative) + Pneumococcal Polysaccharide Vaccine (Pneumovax® 23 or an acceptable alternative) at least 28 days prior to receiving the first dose of RLYB
- •Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116.
排除标准
- •Participants that smoke more than 10 cigarettes per week
- •Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus.
- •Pregnant or nursing
- •Donation or loss of greater than 400 mL of blood within 56 days of study enrollment
- •History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.
研究组 & 干预措施
RLYB116 Dose 1
Experimental
RLYB116 for Injection Dose 1, weekly for 5 weeks
干预措施: RLYB116 for Injection (Drug)
RLYB116 Dose 2
Experimental
RLYB116 for Injection Dose 2, weekly for 5 weeks
干预措施: RLYB116 for Injection (Drug)
Placebo for Injection
Placebo Comparator
Sodium chloride injection, 0.9% saline (for both RLYB116 doses), weekly for 5 weeks
干预措施: RLYB116 for Injection (Drug)
结局指标
主要结局
Number of participants with treatment related adverse events as defined by CTCAE 5.0.
时间窗: From baseline to Day 1, 2, 3, 4, 5, 8, 9, 15, 16, 22, 23, 29, 30, 32, 33, 36, 43, 57, 71, 99
次要结局
- Inhibition of complement activation measured by free/total C5 concentrations and hemolytic activity(Day 1, 2, 8, 15, 29, 20, 32, 33, 43, 57, 71, 99)
- Anti-RLYB116 antibodies measured in serum(Day 1, 29, 99)
- Exposure to RLYB116 as measured in serum(Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99)
研究者
研究点 (1)
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