Single-center, Randomized, Double-blind, Placebo-controlled, Ascending-Dose Study to Evaluate the Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin (Rhu-pGSN) After Intravenous Administration to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation, parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body weight. Each of 4 dosing cohorts will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects). Subjects will be healthy adult volunteers 18-55 years of age.
详细描述
Doses will be administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4). Subjects will be kept in-house until after the last blood sample is taken on Day 5. Subjects will return for follow-up 7 days after the initiation of therapy (Day 8) and on Day 28 for the End-of-Study (EOS) Visit. After each cohort has completed the Day 8 visit, review of the safety results (including labs) will be conducted (and unblinded where appropriate) before the initiation of the next higher dose cohort.
To assess safety and tolerability, subjects will undergo physical examinations (including vital sign measurements), adverse event (AE) assessments, concomitant medication assessments, and safety laboratory testing. Blood samples will be collected for analysis of pGSN levels and antibodies against pGSN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Doses prepared by unblinded pharmacist. Placebo and Drug are undistinguishable in syringe for administration.
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
- •Healthy male or female adults 18 to 55 years of age without chronic or active acute medical conditions
- •Informed consent obtained from subject
- •Weight ≤100 kg and body mass index (BMI) <30 kg/m2
- •Willingness to use contraception during the course of the study, starting at screening and for at least 3 months after their final study treatment
排除标准
- •Pregnant or lactating women
- •Acute illness during the month prior to screening
- •Circumstances that may require any medications (including prescription medication, over-the-counter medication, vitamins, or supplements) during the during the inpatient days of the study other than acetaminophen
- •Hospitalization during the year prior to screening
- •History of cancer or treatment with systemic chemotherapy or radiation therapy at any time
- •Transplantation of hematopoietic or solid organs
- •History of diabetes mellitus; myocardial infarction, angina, or other cardiovascular disease; stroke or cerebrovascular disease; chronic obstructive pulmonary disease (COPD) or asthma; deep vein thrombosis (DVT)/pulmonary embolism (PE); liver or kidney disease; clinically significant psychiatric condition; or active or chronic infection
- •Receipt of blood products during the year prior to screening
- •Chronic mechanical ventilation or dialysis
- •Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
- •Any clinically significant abnormalities of vital signs, EKG or physical examination findings as judged by the Investigator
- •Positive results for recreational drugs during screening
- •Any other condition deemed by the Investigator as possibly interfering with the conduct of the study
研究组 & 干预措施
rhu-pGSN
Treated with 5 doses of rhu-pGSN
干预措施: Recombinant human plasma gelsolin (Drug)
normal saline
Treated with 5 doses of saline
干预措施: placebo (Other)
结局指标
主要结局
Adverse Events
时间窗: 28 days
Number of subjects who had an Adverse Event
Serious Adverse Events
时间窗: 28 days
Number of subjects who had a Serious Adverse Event
次要结局
- Pharmacokinetics: pGSN Concentration(108 hours)
- Pharmacokinetics: pGSN Area Under the Curve (AUC)(108 hours)
- Pharmacokinetics: pGSN Half-life(108 hours)
- Presence of Anti-drug Antibodies(28 days)