NCT01357421已完成1 期
A Phase 1 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effects of a Single Intravenous Dose of TT301 on LPS-induced Changes in Blood Cytokine Levels in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cytokine levels post LPS challenge
研究概览
简要总结
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
详细描述
The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 to 40 years, inclusive
- •55 - 95 kg, inclusive
排除标准
- •Evidence of any clinically significant disease
- •History of cancer
- •History of syncope or severe vasovagal events
- •Antibiotic treatment within 60 days of Day 1
- •Surgical procedure within 60 days of Day 1
- •Hepatitis C, Hepatitis B
- •Tuberculosis
- •Requirement for medications (prescription/OTC) during the study
- •Donated > 250 mL blood within 30 days of Day 1
- •Donated > 750 mL blood within 60 days of Day 1
- •In a clinical trial of an immunosuppressive drug within 6 months of Day 1
- •Received any vaccination within 6 months of Day 1
- •Any clinically important allergy
- •Known allergy/sensitivity to lactose and/or polyethylene glycol
研究组 & 干预措施
TT301
Experimental
Investigational drug TT301
干预措施: TT301 (Drug)
Placebo
Placebo Comparator
Normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Cytokine levels post LPS challenge
时间窗: Measured up to 12h post-LPS
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's DiseaseHealthy SubjectsCrohns DiseaseNCT05452304AstraZeneca112
已完成
1 期
A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.Healthy SubjectsNCT00721344Mannkind Corporation48
已完成
1 期
Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese ParticipantsHealthy VolunteerNCT05070312AstraZeneca39
撤回
1 期
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy VolunteersChronic Obstructive Pulmonary DiseaseNCT00914433Syntara
已完成
1 期
A Study on the Safety, Tolerability and Immune Response of SARS-CoV-2 Sclamp (COVID-19) Vaccine in Healthy AdultsSARS-CoV2Covid19NCT04495933The University of Queensland216