First-in-Human Study Testing a New Antibody Treatment for Tick-Borne Encephalitis in Healthy Volu… (NCT07377253) | Clinical Trial Compass
Not Yet RecruitingPhase 1
First-in-Human Study Testing a New Antibody Treatment for Tick-Borne Encephalitis in Healthy Volunteers.
Switzerland18 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) of TBE025
Timeframe: Up to 84 days after the infusion
2
Incidence and severity of adverse events (AEs)
Timeframe: Up to 84 days after the infusion
3
Incidence and severity of Dose Limiting Toxicity (DLT)