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
- 21
- 试验地点
- 1
- 主要终点
- safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
研究概览
简要总结
In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.
详细描述
The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is considered as a critical factor in the development of multiple sclerosis.
This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 subjects as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at Screening and confirmed at Day -1 who have signed the informed consent.
- •Aged from 18 to 55 years, both inclusive.
排除标准
- •History of serious adverse reactions or hypersensitivity to any drug.
- •Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis that requires no treatment may be tolerated).
- •Need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study.
- •Participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial.
- •NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
6 mg/kg GNbAC1
7 subjects randomized 5:2 active treatment:placebo
干预措施: GNbAC1 (Drug)
18 mg/kg GNbAC1
7 subjects randomized 5:2 active treatment:placebo
干预措施: GNbAC1 (Drug)
36 mg/kg GNbAC1
7 subjects randomized 5:2 active treatment:placebo
干预措施: GNbAC1 (Drug)
结局指标
主要结局
safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
时间窗: 57 days
AE, SAE, vital signs, ECG, clinical laboratory values
次要结局
- PK characteristics: GNbAC1 serum concentrations(57 days)
- immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)(57 days)
- ratio of serum to CSF GNbAC1 concentration(29 days)