NCT05074459已完成1 期
Interventional, Randomized, Double-blind, Parallel-group, Healthy Subject, Single Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab Manufactured Using Two Different Cell Lines
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)
研究概览
简要总结
Eptinezumab is a preventive treatment for migraine. The drug is made from a process that currently uses yeast cells for production of the drug. The trial researchers want to test whether using a new production cell line to make eptinezumab will affect the way the drug behaves in the body. To do this, the researchers will give a single dose of eptinezumab to healthy participants. Some of the participants will get eptinezumab that has been made from yeast cells. Others will get eptinezumab made with the new cell line.
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
- •The participant has a body weight ≥50 and ≤100 kilograms (kg).
- •The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/meter (m^2) at the screening visit and at the baseline visit.
- •The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the screening visit and at the baseline visit.
- •The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the screening visit and at the baseline visit.
- •The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
排除标准
- •The participant has taken disallowed medication <1 week prior to the dose of investigational medicinal product (IMP) or <5 half-lives prior to the screening visit for any medication taken.
- •The participant has taken any IMP <3 months or <5 half-lives (whichever is longer) prior to the first dose of IMP.
- •The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- •The participant has been dosed with a monoclonal antibody (mAb) ≤6 months prior to the screening visit.
- •The participant is a smoker or uses other nicotine-containing products (for example, snuff, nicotine patches, nicotine chewing gum, mock cigarettes, inhalers). Ex-smokers must have ceased smoking >3 months prior to the screening visit.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Eptinezumab Mammalian Cell Line
Experimental
Participants will receive a single intravenous (IV) infusion of eptinezumab mammalian cell line on Day 1.
干预措施: Eptinezumab Mammalian Cell Line (Drug)
Eptinezumab Yeast Cell Line
Active Comparator
Participants will receive a single IV infusion of eptinezumab yeast cell line on Day 1.
干预措施: Eptinezumab Yeast Cell Line (Drug)
结局指标
主要结局
Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)
时间窗: Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140
次要结局
- Percent Extrapolated AUC of Total AUC0-inf (AUC%extr)(Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140)
- Maximal Observed Plasma Concentration (Cmax)(Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140)
- Apparent Volume of Distribution (Vz)(Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140)
- Systemic Clearance (CL), Defined as Dose/AUC0-inf(Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140)
- Area Under the Plasma Concentration-Time Curve From Zero to Time t (AUC0-t)(Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140)
- Apparent Terminal Elimination Half-Life (t½)(Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140)
研究者
研究点 (1)
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