NCT00542464已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- To evaluate the safety and tolerability of 7 consecutive daily i.v. doses of Imprime PGG versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of treatment-emergent adverse events (AE).
研究概览
简要总结
The study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple-dose (7 day), dose-escalation study assessing the safety, pharmacodynamics, and pharmacokinetics of intravenous Imprime PGG™ Injection in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be aged 18 to 45 years, inclusive
- •Have a body weight of 45 to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
- •If female, be non-pregnant and non-nursing, and if pre-menopausal, have a negative serum pregnancy test confirmed prior to enrollment and practicing at least two methods of birth control
- •Be healthy as determined by the investigator on the basis of medical history, physical examination, electrocardiogram, and clinical laboratory test results
- •Have the ability to understand the requirements of the study, provide written informed consent, and agree to abide by the study restrictions and to return for the required assessments
- •Have provided written authorization for use and disclosure of protected health information
排除标准
- •Have a known hypersensitivity to baker's yeast
- •Have a history of tobacco use within 3 months of first day of screening
- •Be a known or suspected abuser of alcohol or other drugs/substances of abuse at anytime
- •Have an active yeast infection
- •Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
- •Except as otherwise indicated, have taken any prescription medication within 30 days of the last day of screening (Day -1) or over-the-counter medication, herbal preparation, or vitamins within 7 days of the last day of screening (Day -1); the following medications are exempted from this criterion: acetaminophen [maximum 3 g/day], female hormone replacement therapy, and oral contraceptives
- •Have participated in an investigational drug study within 30 days or five half lives (whichever is longer) of the last day of screening (Day -1) or have ever participated in a study with Imprime PGG or Betafectin
- •Have donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)
- •Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective
结局指标
主要结局
To evaluate the safety and tolerability of 7 consecutive daily i.v. doses of Imprime PGG versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of treatment-emergent adverse events (AE).
时间窗: Prospective
次要结局
- -To determine the pharmacodynamics of 7 consecutive daily intravenous doses of Imprime PGG by assessing the number of subjects who experience a 15% or more increase from baseline in the percentage of neutrophils with primed complement receptor (CR3).(Prospective)
- -To derive the pharmacokinetic profile of 7 consecutive daily intravenous doses of Imprime PGG when administered to healthy adult subjects by assessing the plasma concentration of Imprime PGG versus time profiles.(Prospective)
研究者
相似试验
已完成
1 期
A Study of STSA-1002 in Healthy SubjectsHealthy SubjectNCT05497635Staidson (Beijing) Biopharmaceuticals Co., Ltd26
招募中
1 期
A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemiaNCT06772766Mabwell (Shanghai) Bioscience Co., Ltd.40
已完成
1 期
Safety and Efficacy of TLL018 in Patients With Plaque PsoriasisModerate to Severe Plaque PsoriasisNCT05342428Hangzhou Highlightll Pharmaceutical Co., Ltd73
终止
3 期
Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPDCOPDNCT02685293Pearl Therapeutics, Inc.4
已完成
2 期
Efficacy and Safety Study of SUNPG1623Active Psoriatic ArthritisNCT02980692Sun Pharmaceutical Industries Limited391