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

NCT07377253 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SVRI01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Tick-borne encephalitis; Tick-borne encephalitis virus; Human antibody therapy; Healthy volunteers; Phase I clinical trial; Intravenous administration; Monoclonal antibody

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD) of TBE025

  Number and percentage of subjects experiencing AEs, SAEs, AEs related to investigational product at each dose level

  Up to 84 days after the infusion

• Incidence and severity of adverse events (AEs)

  Number and percentage of subjects experiencing AEs related to investigational product and the severity of the AEs at each dose level

  Up to 84 days after the infusion

• Incidence and severity of Dose Limiting Toxicity (DLT)

  Number and percentage of participants experiencing DLTs at each dose level.

  Up to 21 days after the infusion.

Secondary Outcomes (2)

• Pharmacokinetic profile of TBE025

  up to 84 days after infusion

• Presence of anti-drug antibodies

  Up to 84 days after infusion

Study Arms (3)

Cohort 1

EXPERIMENTAL

TBE025 200 mg administered intravenously on Day 0

Drug: Human monoclonal antibody TBE025, intravenous infusion

Cohort 2

EXPERIMENTAL

TBE025 600 mg administered intravenously on Day 0

Drug: Human monoclonal antibody TBE025, intravenous infusion

Cohort 3

EXPERIMENTAL

TBE025 2000 mg administered intravenously on Day 0

Drug: Human monoclonal antibody TBE025, intravenous infusion

Interventions

Human monoclonal antibody TBE025, intravenous infusion DRUG

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.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Giuseppe Pantaleo: lead
• Rockefeller University: collaborator

Study Sites (1)

Centre Universitaire Hospitalier Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Central Study Contacts

Laura Molinari

CONTACT

+41795560626; laura.molinari@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Phase I, Dose escalation 3+3, Non randomized, Open Label.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 29, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)