A Phase 1, Randomized, Open-Label, Pharmacokinetic Trial of TAK-881 and HyQvia in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day1-29) Based on Serum Total Immunoglobulin G (IgG) Levels
研究概览
简要总结
The main aim of this study is to understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia, after they are given as a single injection under the skin in healthy adults.
Study participants will receive a single dose of TAK-881 or HyQvia on Day 1.
During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women between 18 and 50 years can participate.
- •Must be a non-smoker, with no use of nicotine or tobacco products.
- •Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg).
- •Must be medically healthy.
- •Must follow protocol-specified contraception guidance.
排除标准
- •Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
- •History of alcohol or drug abuse within 2 years before dosing.
- •History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
- •History or presence of thrombotic/thromboembolic events, or venous thrombosis.
- •Pregnant or breastfeeding.
- •Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
- •Recently donated blood or blood products.
- •Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
- •Has taken biologic agents within 12 weeks of screening.
- •Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
- •Has received any vaccine (including live attenuated vaccines and COVID-19 vaccines) during the last 30 days before dosing.
研究组 & 干预措施
TAK-881 1.0 g/kg
Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1.
干预措施: TAK-881 (Biological)
TAK-881 1.0 g/kg
Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1.
干预措施: SC Investigational Needle Sets (Device)
HyQvia 1g/kg
Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.
干预措施: HyQvia (Biological)
HyQvia 1g/kg
Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.
干预措施: SC Investigational Needle Sets (Device)
结局指标
主要结局
Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day1-29) Based on Serum Total Immunoglobulin G (IgG) Levels
时间窗: Day 1 up to Day 29
次要结局
- Baseline-Uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels(From Screening up to Day 85)
- Baseline-Uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels(From Screening up to Day 85)
- Baseline-Uncorrected AUC Day1-29 Based on Serum Total IgG Levels(Day 1 up to Day 29)
- Baseline-corrected AUC from Day 1 to infinity (AUCinf) Based on Serum Total IgG Levels(From Day 1 up to Day 85)
- Baseline-corrected AUC from Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels(From Day 1 up to Day 85)
- Baseline-corrected Cmax Based on Serum Total IgG Levels(From Day 1 up to Day 85)
- Baseline-corrected Tmax Based on Serum Total IgG Levels(From Day 1 up to Day 85)
- Baseline-corrected Time of last measurable concentration (Tlast) Based on Serum Total IgG Levels(From Day 1 up to Day 85)
- Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels(From Day 1 up to Day 85)
- Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels(From Day 1 up to Day 85)
- Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels(From Day up to Day 85)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From first dose of study drug up to Day 85)
- Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions(From first dose of study drug up to Day 85)
- Number of Participants With Positive Binding Antibodies to rHuPH20(From first dose of study drug up to Day 85)
- Number of Participants With Neutralizing Antibodies to rHuPH20(From first dose of study drug up to Day 85)