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First-in-Human Study Testing a New Antibody Treatment for Tick-Borne Encephalitis in Healthy Volunteers.
Sponsor: Giuseppe Pantaleo
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2026-01-01
Completion Date
2026-10-31
Last Updated
2026-01-29
Healthy Volunteers
Yes
Conditions
Interventions
Human monoclonal antibody TBE025, intravenous infusion
TBE025 is a recombinant, fully human monoclonal antibody (mAb). It is provided in single-use vials containing 20 mg/mL of protein in 5 mL of buffered solution consisting of 10 mM Histidine, 250 mM Trehalose, 10 mM Methionine, 0.05% Polysorbate 20 and water for injection, at pH 5.5. TBE025 is a clear to opalescent, colorless to brown liquid.
Locations (1)
Centre Universitaire Hospitalier Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland