NCT07377396招募中1 期
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-124 in Healthy Adult Participants
argenx1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2026年1月26日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation
研究概览
简要总结
This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it. Participants will remain in the study for up to approximately 23 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
- •Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male.
- •Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg/m2, inclusive.
排除标准
- •Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- •Has IgG levels <6.0 g/L at screening.
- •Has a history of an immunosuppressive disease or an immunosuppressive condition at screening.
- •Previously participated in an ARGX-124, ARGX-213, or efgartigimod clinical study and received at least 1 dose of the study drug.
研究组 & 干预措施
ARGX-124
Experimental
Participants receiving the experimental drug
干预措施: ARGX-124 (Biological)
Placebo
Placebo Comparator
Participants receiving placebo
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation
时间窗: Up to 23 weeks
AE : adverse event ; SAE : serious adverse event.
次要结局
- Maximum observed serum concentration (Cmax)(Up to 23 weeks)
- Percent change from baseline in total IgG levels in serum over time(Up to 23 weeks)
- Incidence of ADA against ARGX-124 in serum(Up to 23 weeks)
研究者
研究点 (1)
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