A Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of Intravenous (IV) Administration of a Human Monoclonal Antibody Against Tick-borne Encephalitis Virus in Healthy Adults.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of TBE025
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of the investigational monoclonal antibody TBE025 when given intravenously to healthy adult volunteers aged 18 to 55.
The study aims to determine the recommended Phase II dose of TBE025 and to assess the incidence and severity of adverse events related to its administration.
There is no comparison group, as this is a single-arm, open-label study. Participants will receive a single intravenous infusion of TBE025 at one of three escalating dose levels, will be monitored for safety with regular clinical and laboratory assessments, and will provide blood samples for pharmacokinetic, anti-drug antibody, and neutralization testing.
详细描述
The tick-borne encephalitis virus (TBEV) is an infection spread by ticks that is becoming more common in Europe, including Switzerland. Currently, there is no specific treatment-care focuses on relieving symptoms. Vaccines exist, but few people get vaccinated, and sometimes the vaccine does not offer full protection. There is therefore a real need for new ways to prevent or treat this disease.
TBE025 is a fully human antibody taken from people who have recovered from TBEV. It can strongly block the virus. In lab studies with mice, TBE025 was able to protect against infection, both when given before exposure and soon after infection. It also appears to be safe, with no harmful effects on other tissues.
This first-in-human study (phase 1) will evaluate intravenous administration of TBE025 in healthy adult volunteers using a standard 3+3 dose-escalation design (200 mg, 600 mg, 2000 mg). Between 3 and 18 participants will be enrolled sequentially across three cohorts. The study is designed to establish the maximum tolerated dose and recommended Phase II dose, as well as to characterize the pharmacokinetics, immunogenicity, and neutralization capacity of TBE025.
Participants will be followed for safety, laboratory, and pharmacokinetic assessments over a three-month period. The study will provide the first clinical data on TBE025 in humans and will inform the design of subsequent efficacy trials in populations at risk of TBEV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Adults aged 18 to <55 years
- •Good general health (medical history, physical exam, normal labs)
- •Written informed consent provided
- •Ability to read and understand local language
- •Contraception requirements : Women of childbearing potential: negative pregnancy test, surgically sterile, postmenopausal, or using highly effective contraception for 3 months post-infusion. Men: surgically sterile or using highly effective contraception (self or partner) and abstain from sperm donation for 3 months post-infusion.
排除标准
- •BMI <19 or >30
- •Infections: HIV, active hepatitis B (HBsAg), active hepatitis C
- •Prior participation in investigational study within 30 days
- •History of hypersensitivity to monoclonal antibodies
- •Recent surgery or unresolved adverse events
- •Active autoimmune disease requiring systemic treatment
- •Recent use of immunosuppressive agents or immunoglobulins
- •Immunodeficiency diagnosis
- •Significant cardiovascular events within 6 months
- •Live/attenuated vaccines within 28 days
- •Major surgery within 28 days
- •Pregnancy or breastfeeding
- •Professional or private link with the research team
- •Any condition judged by the investigator to interfere with safety or study results
研究组 & 干预措施
Cohort 1
TBE025 200 mg administered intravenously on Day 0
干预措施: Human monoclonal antibody TBE025, intravenous infusion (Drug)
Cohort 2
TBE025 600 mg administered intravenously on Day 0
干预措施: Human monoclonal antibody TBE025, intravenous infusion (Drug)
Cohort 3
TBE025 2000 mg administered intravenously on Day 0
干预措施: Human monoclonal antibody TBE025, intravenous infusion (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of TBE025
时间窗: Up to 84 days after the infusion
Number and percentage of subjects experiencing AEs, SAEs, AEs related to investigational product at each dose level
Incidence and severity of adverse events (AEs)
时间窗: Up to 84 days after the infusion
Number and percentage of subjects experiencing AEs related to investigational product and the severity of the AEs at each dose level
Incidence and severity of Dose Limiting Toxicity (DLT)
时间窗: Up to 21 days after the infusion.
Number and percentage of participants experiencing DLTs at each dose level.
次要结局
- Pharmacokinetic profile of TBE025(up to 84 days after infusion)
- Presence of anti-drug antibodies(Up to 84 days after infusion)
研究者
Giuseppe Pantaleo
Professor
Centre Hospitalier Universitaire Vaudois