First-in-Human Study Testing a New Antibody Treatment for Tick-Borne Encephalitis in Healthy Volunteers.

Starting soon · Phase 1

Conditions studied: The Tick-borne Encephalitis Virus (TBEV)

In brief

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.

Key facts

Study ID

NCT07377253

Run by

Giuseppe Pantaleo

People needed

18

Starts

2026-01-01

Expected to finish

2026-10-31

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Centre Universitaire Hospitalier Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland

Full record on ClinicalTrials.gov

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