A Randomized, Placebo-Controlled, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Galcanezumab in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab
研究概览
简要总结
The purpose of this study is to assess how fast galcanezumab gets into the blood stream and how long it takes the body to remove it. Information about side effects will be collected. The study is open to healthy Chinese participants. It will last up to about 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
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are native Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin)
- •Participants who are overtly healthy males or females, as determined by medical history and physical examination
排除标准
- •Participants who are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Participants who have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
- •Participants who have received treatment with any CGRP (calcitonin gene related peptide) antibody (including galcanezumab), or antibody against CGRP receptor (including erenumab), or have received biologic agents (such as monoclonal antibodies) within 4 months or 5 half-lives (whichever is longer) prior to dosing
- •Participants who have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or non-prescription drugs or food
- •women who are lactating
- •Participants who show evidence of positive human immunodeficiency virus antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen, or active tuberculosis
研究组 & 干预措施
Galcanezumab
Participants received single subcutaneous (SC) doses of 120 milligram (mg) or 240 mg Galcanezumab.
干预措施: Galcanezumab (Drug)
Placebo
Participants received a single SC dose of Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab
时间窗: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-∞\]) of Galcanezumab.
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
时间窗: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
次要结局
未报告次要终点