A Phase 1, Open-Label, Fixed-Sequence, Randomized Study to Assess the Tolerability and Safety of Subcutaneously Administered Immunoglobulin G With Varying Injection Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)
研究概览
简要总结
This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 18 to 36 kilograms per meter square (kg/m^2), inclusive
- •For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during IgG administration and for 28 days after completion of IgG administration
- •For males: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the last study drug administration
- •Positive human immunodeficiency virus (HIV) test
- •Positive hepatitis B surface antigen or hepatitis B core antibody test
- •Positive hepatitis C virus antibody test
- •Regular alcohol consumption of >8 drinks/week for females or >12 drinks/week for males
- •Poor peripheral venous access
- •Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the study
- •Known hypersensitivity to IgG or any of its components or to products made with IgG
- •History or presence of skin rash or other skin disorders
- •Inability to sense pain (e.g., peripheral neuropathy) or have a history of or have been diagnosed with a chronic pain syndrome
- •Infection or inflammation of the designated injection site (abdomen)
研究组 & 干预措施
Sequence 1
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A.
干预措施: Immunoglobulin G (Drug)
Sequence 2
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C.
干预措施: Immunoglobulin G (Drug)
Sequence 3
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C.
干预措施: Immunoglobulin G (Drug)
Sequence 4
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D.
干预措施: Immunoglobulin G (Drug)
结局指标
主要结局
Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)
时间窗: Up to Day 4
Mean Change From Baseline in Injection Site Tolerability Score on VAS
时间窗: Baseline, Up to Day 4
Percentage of Participants Experiencing Greater Than Mild Pain
时间窗: Up to Day 4
Percentage of Participants in Each VDS Category on the VDS Scale
时间窗: Up to Day 4
Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)
时间窗: Up to Day 7
Participant's Tolerability to Injection as Assessed by Tolerability Questionnaire
时间窗: Up to Day 4
Number of Participants with Visual Injection Site Tolerability as assessed using LISSA
时间窗: Up to Day 4
Number of Participants with Fluid Leakage
时间窗: Up to Day 4
次要结局
未报告次要终点