NCT06968338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-213 in Healthy Adult Participants
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- argenx
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation
研究概览
简要总结
This study aims to assess the safety of ARGX-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body. The participants will remain in the study for approximately up to 21 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 for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF
- •Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male
- •Has a body weight between 50 and 100 kg and a BMI between 18 and 30.5 kg/m^2, 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 results of the study or put the participant at undue risk
- •Has a clinically meaningful abnormality detected on ECG recording regarding either rhythm or conduction
研究组 & 干预措施
ARGX-213
Experimental
Participants receiving the experimental drug
干预措施: ARGX-213 (Biological)
Placebo
Placebo Comparator
Participants receiving placebo
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation
时间窗: Up to 17 weeks
次要结局
- ARGX-213 serum concentrations(Up to 17 weeks)
- Percent change from baseline in total IgG concentrations in serum(Up to 17 weeks)
- Incidence of antidrug antibodies against ARGX-213 in serum(Up to 17 weeks)
研究者
研究点 (1)
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