A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects

A Randomized, Single-blind, Controlled, Monocentric Phase II Trial to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects

The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.

Inclusion Criteria:

• Subjects free of obvious health-problems or with stable condition
• Male or female subjects aged ≥19 to ≤65 years
• BMI between ≥18 and ≤30 kg/m2

Exclusion Criteria:

• Prior history of active or passive rabies immunization
• Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator
• History and/or family history of clinically significant immunodeficiency or auto-immune disease
• Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product