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

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.

Timeline

Start

2026-01-01

Primary completion

2026-05-31

Completion

2026-10-31

Drugs

Indications