A Phase I Study of the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety- Adverse Events
研究概览
简要总结
The goal is to establish the safety of administration of nasal foralumab to healthy volunteers in escalating doses to determine the dose at which immune effects are observed. Patients will receive doses for 5 consecutive days and have a follow-up period.
详细描述
This was a randomized, double blind phase 1 dose escalation study evaluating 3 dose levels of foralumab via intranasal administration from single-dose vials. The rationale behind the proposed research was to establish an immunologically active dose of foralumab given by the nasal route. Given that foralumab has never been administered by the nasal route to humans, this was a safety and dose finding study. Each dose group was observed until Day 7 to assess safety before moving to the next higher dose. This study also helped determine the dose at which immune effects (induction of regulatory T cells and changes in cytokine profiles of immune cells) were observed in subjects treated with foralumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The treating physician and subjects will be blinded to treatment. The BWH IDS pharmacy will have the treatment code assignments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women ages 18 to 65 years
- •Healthy adults
- •Ability and willingness to provide informed consent and comply with study requirements and procedures
排除标准
- •Chronic medical disease compromising organ function
- •Corticosteroids within the past month
- •Pregnancy or lactating
- •Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type I diabetes
- •Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past year.
- •Participation in another clinical trial within the past 30 days
- •Known history of drug or ETOH abuse
- •Screening labs outside of the normal range; EBV IgM positive subjects with clinical signs will not receive study drug
- •Nasal corticosteroids; antihistamines; nasal flu dosing within 30 days
研究组 & 干预措施
nasal foralumab 10 μg daily
Group A: nasal foralumab 10 μg daily for 5 days
干预措施: Foralumab Nasal (Drug)
nasal foralumab 50 μg daily
Group B: nasal foralumab 50 μg daily for 5 days
干预措施: Foralumab Nasal (Drug)
nasal foralumab 250 μg daily
Group C: nasal foralumab 250 μg daily for 5 days
干预措施: Foralumab Nasal (Drug)
placebo
The placebo was acetate buffer. It was handled in a manner identical to active drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety- Adverse Events
时间窗: Day 1 vs End of Study (Day 30)
Establish the safety of administration of nasal Foralumab to healthy volunteers in escalating doses for 5 consecutive days. Two or more serious adverse events occur that are possibly, probably or definitely related to nasal Foralumab.
Immune Effect
时间窗: Dat 1 vs End of Study (Day 30)
Determine the dose at which immune effects are observed in subjects treated with Foralumab
次要结局
未报告次要终点