Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Apparent Total Body Clearance (CLT/F) of SC Belatacept
研究概览
简要总结
Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Men and women ages 18 to 65 years old
- •Subjects must weigh less than or equal to 100 kg
排除标准
- •Inability to tolerate injections or IV infusions
- •autoimmune disorders
- •bacterial or viral infection
- •history of cancer
研究组 & 干预措施
Placebo
SC injection of placebo solution
干预措施: Placebo (Drug)
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
干预措施: belatacept (Drug)
Belatacept 50 mg Subcutaneous Injection
Belatacept 50 mg subcutaneous (SC) injection
干预措施: belatacept (Drug)
Belatacept 100 mg Subcutaneous Injection
Belatacept 100 mg SC injection
干预措施: belatacept (Drug)
Belatacept 125 mg Subcutaneous Injection
Belatacept 125 mg SC injection
干预措施: belatacept (Drug)
Belatacept 150 mg Subcutaneous Injections
2 SC injections of 75 mg Belatacept
干预措施: belatacept (Drug)
Belatacept 200 mg Subcutaneous Injections
2 SC injections of 100 mg Belatacept
干预措施: belatacept (Drug)
Belatacept 250 mg Subcutaneous Injections
2 SC injections of 125 mg Belatacept
干预措施: belatacept (Drug)
结局指标
主要结局
Apparent Total Body Clearance (CLT/F) of SC Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).
Maximum Observed Serum Concentration (Cmax) of Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\*h/mL).
Time of Maximum Observed Serum Concentration (Tmax) of Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\*h/mL)
Serum Half-life (T-HALF) of Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.
Total Body Clearance (CLT) of IV Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)
Volume of Distribution at Steady State (VSS) for IV Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.
Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept
时间窗: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.
次要结局
- Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption(Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116)
- Number of Participants With Vital Sign Abnormalities(1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116)
- Number of Participants With Injection Site Reactions(0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116)
- Number of Participants With Physical Examination Abnormalities(Days 1, 2, 5, 14, 28, 42, 86, 116)
- Number of Participants With Electrocardiogram (ECG) Abnormalities(Days 1 and 116)
- Number of Participants With Marked Hematology Laboratory Abnormalities(Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116)
- Number of Participants With Marked Serum Chemistry Abnormalities(Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116)
- Number of Participants With Marked Laboratory Abnormalities(Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116)
- Number of Participants With Positive Immunogenicity to Belatacept(Days 1, 14, 28, 42, 56, 86, 116)