A Phase 1, 3-Part, Single Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lu AG22515 (APB-A1) in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥18.0 and ≤32.0 kilograms (kg)/square meter (m^2) and weight between 55 and 110 kg (both inclusive) at screening.
- •Fully vaccinated against COVID-19, as evidenced by presentation of a vaccine card. The last administration of the COVID-19 vaccination must be received a minimum of 30 days and maximum 6 month prior to dosing in this study.
- •Medically healthy with no clinically significant medical history, physical examination and neurological assessment, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
- •Part C only:
- •The participant is Japanese, defined as being born in Japan and having four Japanese grandparents as well as living a Japanese lifestyle as confirmed by the Japanese lifestyle questionnaire.
排除标准
- •Reported history of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •Received any vaccination in the last 30 days prior to Day
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part C: Placebo
Participants will receive a single IV infusion of placebo matching to Lu AG22515.
干预措施: Placebo (Drug)
Part A: Lu AG22515
Participants will receive a single intravenous (IV) infusion of Lu AG22515.
干预措施: Lu AG22515 (Drug)
Part A: Placebo
Participants will receive a single IV infusion of placebo matching to Lu AG22515.
干预措施: Placebo (Drug)
Part B: Lu AG22515 and Immune System Activator
Participants will receive a single IV infusion of Lu AG22515 and a subcutaneous (SC) injection of immune system activator 14 days prior to and 14 days following the start of Lu AG22515 IV infusion.
干预措施: Lu AG22515 (Drug)
Part B: Lu AG22515 and Immune System Activator
Participants will receive a single IV infusion of Lu AG22515 and a subcutaneous (SC) injection of immune system activator 14 days prior to and 14 days following the start of Lu AG22515 IV infusion.
干预措施: Immune System Activator (Drug)
Part B: Placebo and Immune System Activator
Participants will receive a single IV infusion of placebo matching to Lu AG22515 and an SC injection of immune system activator 14 days prior to and 14 days following the start of placebo IV infusion.
干预措施: Placebo (Drug)
Part B: Placebo and Immune System Activator
Participants will receive a single IV infusion of placebo matching to Lu AG22515 and an SC injection of immune system activator 14 days prior to and 14 days following the start of placebo IV infusion.
干预措施: Immune System Activator (Drug)
Part C: Lu AG22515
Participants will receive a single intravenous (IV) infusion of Lu AG22515.
干预措施: Lu AG22515 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From the day of study drug administration (Day 1) up to end of study (Day 113)
次要结局
- Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))
- Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))
- Apparent Total Serum Clearance (CL) of Lu AG22515(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))
- Number of Participants With Anti-Drug Antibodies (ADAs)(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))
- Maximum Observed Plasma Concentration (Cmax) of Lu AG22515(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))
- Time to Reach Cmax (Tmax) of Lu AG22515(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))
- Apparent Elimination Half-life (t1/2) of Lu AG22515(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))
- Mean Residence Time (MRT) of Lu AG22515(Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113))