A Phase 1, Open-Label, Randomized, Single Dose, Parallel-Group Study to Assess the Absolute Bioavailability and Evaluate the Effect of Body Weight on the Pharmacokinetics of Adimanebart SC in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- argenx
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- AUC0-inf
研究概览
简要总结
This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed.
The participants will be assigned to one of 3 parts of the study: part 1 investigates the absolute bioavailability; part 2 investigates the effect of different body weights on adimanebart in blood after subcutaneous (SC) dosing; part 3 investigates formulation adaptations.
Participants will be in the study for approximately up to 24 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
- None
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.
- •Has a body weight between 60 and 100 kg and a BMI between 18.5 and 30 kg/m2, inclusive, at screening and on day -1 for part 1 and part 3, or has a body weight <60 kg or between 100 and 130 kg and a BMI between 18.5 and 38.0 kg/m2, inclusive, at screening and on day -1 for part
- •Discontinues and refrains from using all medications, including nonprescription and prescription medications, for ≥2 weeks before IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
排除标准
- •Has any current or past clinically meaningful medical or psychiatric condition, including severe hypersensitivity reactions to drugs and/or food that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- •Previously participated in an adimanebart clinical study and received at least 1 dose of IMP.
- •Is currently participating in another interventional clinical study, or has received an IMP in another clinical study within 12 weeks or 5 half-lives (whichever is longer) before screening.
研究组 & 干预措施
Part 1 - Adimanebart IV
Participants randomized to receive adimanebart IV
干预措施: Adimanebart IV (Biological)
Part 1 - Adimanebart SC (formulation A)
Participants randomized to receive adimanebart SC
干预措施: Adimanebart SC - formulation A (Biological)
Part 2 - Adimanebart SC (formulation A) in lower body weights
Participants with body weight < 60 kg will receive adimanebart SC
干预措施: Adimanebart SC - formulation A (Biological)
Part 2 - Adimanebart SC (formulation A) in higher body weights
Participants with body weight between 100 and 130 kg will receive adimanebart SC
干预措施: Adimanebart SC - formulation A (Biological)
Part 3 - Adimanebart SC (formulation B)
Participants randomized to receive adimanebart SC formulation B
干预措施: Adimanebart SC - formulation B (Biological)
Part 3 - Adimanebart SC (formulation C)
Participants randomized to receive adimanebart SC formulation C
干预措施: Adimanebart SC - formulation C (Biological)
结局指标
主要结局
AUC0-inf
时间窗: Up to 20 weeks
AUC0-inf = area under the concentration-time curve from time 0 to infinity
次要结局
- adimanebart SC PK parameter: Cmax(Up to 20 weeks)
- Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation(Up to 20 weeks)