Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Investigating the Effect of Lu AG09222 on PACAP38- and VIP-induced Vasodilation, Heart Rate Increase, and Headache in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) of change from start of infusion in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38
研究概览
简要总结
The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.
详细描述
This study will investigate the effect of preventive treatment with Lu AG09222 on vasodilation, heart rate increase, and headache induced by PACAP and VIP.
Subjects will be randomised to three arms, placebo + saline, placebo + VIP and PACAP, and Lu AG09222 + VIP and PACAP. Subjects who complete the study will attend a safety follow-up visit at 10 to 12 weeks after administration of investigational medicinal product.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject has a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, and a body weight ≥ 45 and ≤ 95 kg at the screening visit.
- •The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests at screening.
排除标准
- •The subject fulfils the diagnostic criteria for a primary headache disorder, or has a first degree relative with a primary headache disorder, according to the International Headache Society (IHS) International Classification of Headache Disorders 3rd edition (ICHD-3), except tension-type headache.
- •The subject has or has had tension-type headache more than once per month on average during the 6 months prior to the screening visit.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo + saline
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
干预措施: Placebo (Drug)
Placebo + VIP and PACAP
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
干预措施: Placebo (Drug)
Lu AG09222 + VIP and PACAP
Lu AG09222, single dose intravenous infusion over 30 minutes
干预措施: Lu AG09222 (Drug)
结局指标
主要结局
Area under the curve (AUC) of change from start of infusion in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38
时间窗: 0 to 120 min after infusion
次要结局
- Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38(0 to 60 min after infusion)
- Maximum change from start of infusion in STA diameter between 0 and 120 min after start of infusion of PACAP38(0 and 120 min after infusion)
- AUC in change from start of infusion in facial blood flow from 0 to 120 min after start of infusion of PACAP38(0 to 120 min after infusion)
- AUC in change from start of infusion in heart rate from 0 to 120 min after start of infusion of PACAP38(0 to 120 min after infusion)