A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRA023 in Healthy Caucasian and Japanese Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- F% in Caucasian subjects
研究概览
简要总结
This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers
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
- Double (Participant, Investigator)
盲法说明
Double Blind
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
- •Subjects are required to meet the following criteria in order to be included in the study:
- •Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin.
- •Caucasian subjects must be of European or Latin American descent (i.e., White).
- •Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 55 years of age.
- •Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:
- •hysteroscopic sterilization;
- •bilateral tubal ligation or bilateral salpingectomy;
- •hysterectomy;
- •bilateral oophorectomy, or;
- •be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per Investigator judgment.
- •Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days after the end of dosing.
- •Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.
排除标准
- •Subjects with the following characteristics will be excluded from the study:
- •History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- •Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 60-90mmHg diastolic, heart rate 60-100 beats/min.
- •12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 120 milliseconds (msec), or QTcF interval of > 450 msec for men or > 470msec for women.
- •Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
- •Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
- •History of or current active tuberculosis (TB) infection; history of latent TB that has not been fully treated or current latent TB infection as indicated by a positive QuantiFERON-TB test.
- •History of significant allergy to any medication as judged by the Investigator.
- •History of alcohol or drug abuse within the past 24 months.
研究组 & 干预措施
Placebo SC/PRA023 IV High Dose
干预措施: PRA023 IV High Dose (Drug)
Placebo SC/Placebo IV
Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion
干预措施: Placebo SC (Drug)
PRA023 SC/Placebo IV
Participants randomized to receive active subcutaneous injection/placebo intravenous infusion
干预措施: PRA023 SC (Drug)
PRA023 SC/Placebo IV
Participants randomized to receive active subcutaneous injection/placebo intravenous infusion
干预措施: Placebo IV (Drug)
Placebo SC/PRA023 IV Low Dose
Participants randomized to receive placebo subcutaneous injection/active intravenous infusion
干预措施: PRA023 IV Low Dose (Drug)
Placebo SC/PRA023 IV Low Dose
Participants randomized to receive placebo subcutaneous injection/active intravenous infusion
干预措施: Placebo SC (Drug)
Placebo SC/Placebo IV
Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion
干预措施: Placebo IV (Drug)
Placebo SC/PRA023 IV High Dose
干预措施: Placebo SC (Drug)
结局指标
主要结局
F% in Caucasian subjects
时间窗: Up to 10 Weeks
Mean SC versus IV AUC(inf) values
Cmax in Japanese subjects
时间窗: Up to 14 Weeks
Maximum concentration after single dose
Incidence, severity, causal relationship of treatment emergent adverse events
时间窗: Up to 14 Weeks
Tmax in Japanese subjects
时间窗: Up to 14 Weeks
Time to reach maximum concentration after single dose
次要结局
- Change in sTL1A levels(Up to 14 Weeks)
- Cmax in Caucasian subjects(Up to 10 Weeks)
- Immunogenicity rate(Up to 14 Weeks)
- Tmax in Caucasian subjects(Up to 10 Weeks)