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

NCT07377253 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

  • The Tick-borne Encephalitis Virus (TBEV)

Interventions

DRUG

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.

Sponsors & Collaborators

  • Rockefeller University

    collaborator OTHER

  • Giuseppe Pantaleo

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-05-31
Completion
2026-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377253 on ClinicalTrials.gov