A First-in-Human, Ascending Dose, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of UKK-0018 in Peanut Allergic Individuals
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of solicited local and systemic adverse reactions
研究概览
简要总结
This study will test a new investigational treatment called UKK-0018. UKK-0018 as an immunotherapeutic for the treatment of peanut allergies. The treatment is given by injection and is designed to train the immune system to tolerate peanut exposure over time.
详细描述
The study will assess how safe and well tolerated UKK-0018 is in people with known peanut allergy, and whether it can reduce the risk of allergic symptoms following exposure to peanut proteins.
This is a first-in-human, open-label, multicenter study that will be conducted in adult participants with peanut allergy evaluating dose levels and regimens. It is anticipated that UKK-0018 can help retrain the immune system over time to respond safely to peanut proteins in case of accidental exposures. The modifications which reduce binding to IgE antibodies are anticipated to reduce risk of serious allergic reactions compared to standard of care.
Based on emerging data an optional dose expansion cohort may be added. An optional dose expansion cohort may be added if supported by emerging data. The study is comprised of a screening period, intervention period, and follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-55 years old
- •documented history of physician-diagnosed peanut allergy
- •positive skin prick test (SPT)
- •screening DBPCFC peanut protein
- •contraception use should be consistent with local regulations
- •capable of providing signed written informed consent
排除标准
- •asthma based on NHLBI
- •uncontrolled cardiovascular disease
- •chronic disease history
- •exacerbation of dermatological conditions
- •life threatening episodes of anaphylaxis
- •active infections
- •poor physical or blood chemistry
- •immunodeficiency, bleeding disorders, malignancies
- •hypersensitivities to epinephrine, inactive ingredients in therapy
- •pregnant or breast feeding
研究组 & 干预措施
UKK-0018
UKK0018 is an immunotherapeutic for the treatment of peanut allergies
干预措施: UKK-0018 (Biological)
结局指标
主要结局
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of solicited local and systemic adverse reactions
时间窗: 7 days after each injection
Numbers and percentages of participants with solicited local and systemic adverse reactions
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of unsolicited adverse events
时间窗: 28 days after each injection
Numbers and percentages of participants with unsolicited adverse events (AEs)
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of medically-attended adverse events (MAAEs
时间窗: 30 weeks after first injection
Numbers and percentages of participants with medically-attended adverse events (MAAEs)
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of adverse events of special interest (AESI)
时间窗: 30 weeks after first injection
Numbers and percentages of participants with adverse events of special interest (AESI)
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of serious adverse events (SAE)
时间窗: 30 weeks after first injection
Numbers and percentages of participants with serious adverse events (SAE)
次要结局
- To assess the preliminary efficacy of repeated dosing of UKK-0018 administered IM in participants with peanut allergy(at 28 days post last treatment)
- To assess the preliminary efficacy of repeated IM dosing of UKK-0018 in participants with peanut allergy(at 28 days post treatment)
- To assess the preliminary efficacy of repeated dosing of UKK-0018 administered IM in participants with peanut allergy(at 24 weeks post last treatment)
- To assess the preliminary efficacy of repeated IM dosing of UKK-0018 in participants with peanut allergy(at 24 weeks post treatment)
- To assess the effect of dose regimen on immunogenicity and biomarkers following repeated IM dosing of UKK-0018(up to 30 weeks)