A Randomized Study to Investigate Injection-Site Pain Following Subcutaneous Injections of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation Using a Pre-filled Syringe in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Injection Pain Visual Analog Scale (VAS) Score
研究概览
简要总结
The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions [ISRs]) will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male participants or female participants who agree not to get pregnant
- •Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study
排除标准
- •Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
- •Are allergic or hypersensitive to the study medicine
- •Have dullness or loss of sensitivity on either side of your abdomen
- •Have any condition that could affect pain perception from an injection
- •Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
- •Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
- •Show evidence of active or latent tuberculosis (TB)
- •Presence of significant neuropsychiatric disorder or a recent history of depression
- •Have excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments
- •Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant if participating in the study
研究组 & 干预措施
Ixekizumab (Test 2)
Test 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
干预措施: Ixekizumab (Biological)
Ixekizumab (Test 1)
Test 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
干预措施: Ixekizumab (Biological)
Ixekizumab (Reference)
Reference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.
干预措施: Ixekizumab (Biological)
结局指标
主要结局
Injection Pain Visual Analog Scale (VAS) Score
时间窗: Day 1, 8, and 15: Immediately (within 1 minute) after injection
The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (\>30 and ≤70), and severe pain (\>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).
次要结局
未报告次要终点