Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xencor, Inc.
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Vz, Volume of distribution
研究概览
简要总结
An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers.
详细描述
The study will enroll approximately 50 eligible healthy male and female subjects between the ages of 18 to 55 inclusive. There will be 5 parallel dose cohorts (Cohorts 1-5) consisting of 10 subjects in each cohort. No subject will be a member of more than 1 cohort. Subjects will receive 3 administrations of study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are adult males and females aged 18 to 55 years inclusive as of dosing (Day 1) with total body weight between 45.0 and 100.0 kg inclusive and body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive;
- •Healthy as assessed by the Investigator with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
排除标准
- •Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- •Subjects who are positive for drugs of abuse or alcohol on screening or admission;
- •Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb
- •Subjects who have used prescription drugs (with the exception of hormonal birth control for women of child-bearing potential) within 14 days or 5 half-lives, whichever is longer, prior to dosing (Day 1), unless agreed as not clinically relevant by the Principal Investigator and Sponsor.
- •Subjects who have received live vaccines ≤3 months from Day
- •Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin).
- •Unable or unwilling to partake in follow-up assessments or required protocol procedures.
研究组 & 干预措施
Cohort 1
Dose Level 1 XmAb5871 given SC Q14days X 3
干预措施: XmAb5871 (Drug)
Cohort 2
Dose Level 2 XmAb5871 given SC Q14days X 3
干预措施: XmAb5871 (Drug)
Cohort 3
Dose Level 3 XmAb5871 given SC Q14days X 3
干预措施: XmAb5871 (Drug)
Cohort 4
Dose Level 4 XmAb5871 given IV Q14days X 3
干预措施: XmAb5871 (Drug)
Cohort 5
Dose Level 5 XmAb5871 given SC Q7days X 3
干预措施: XmAb5871 (Drug)
结局指标
主要结局
Vz, Volume of distribution
时间窗: Date of enrollment to Day 57
AUC, Area under the plasma concentration versus time curve
时间窗: Date of enrollment to Day 57
Cmax, Maximum observed serum concentration
时间窗: Date of enrollment to Day 57
F, bioavailability of a SC dose relative to an IV dose
时间窗: Date of enrollment to Day 57
Number of participants with adverse events that are related to treatment
时间窗: Date of enrollment to Day 57
Number of participants with severe adverse events that are related to treatment
时间窗: Date of enrollment to Day 57
Number of participants with abnormal laboratory values related to treatment
时间窗: Date of enrollment to Day 57
Number of participants with abnormal ECGs related to treatment
时间窗: Date of enrollment to Day 57
Tmax, Time of maximum observed serum concentration
时间窗: Date of enrollment to Day 57
CL, Clearance of drug from the body
时间窗: Date of enrollment to Day 57
次要结局
- Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57(Date of enrollment to Day 57)
- Percent of participants positive in the assay at at least one time point(Date of enrollment to Day 57)
- Percent of participants with increasing titers of anti-drug antibody over time(Date of enrollment to Day 57)