A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
研究概览
简要总结
This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •Negative urine drug screen
- •Have signed the informed consent.
排除标准
- •History of serious adverse reactions or hypersensitivity to any drug.
- •Use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. Permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.
研究组 & 干预措施
Cohort 1
GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 Placebo (Other)
Cohort 1
GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 (Drug)
Cohort 2
GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 (Drug)
Cohort 2
GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 Placebo (Other)
Cohort 3
GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 (Drug)
Cohort 3
GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 Placebo (Other)
Cohort 4
GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 (Drug)
Cohort 4
GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
干预措施: GNbAC1 Placebo (Other)
结局指标
主要结局
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
时间窗: 57 days
Serious Adverse Events (SAE), Adverse Events (AE)
次要结局
- Pharmacokinetic (PK): GNbAC1 serum concentrations over time(57 days)
- Immunogenicity: Antibodies against GNbAC1 (ADA)(57 days)