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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Rabies

Intervention / Treatment
-----------------
* Biological: CL184
* Biological: HRIG
* Biological: Placebo matching CL184


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>CL184 combined with rabies vaccination | Biological: CL184<br>* CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28<br>|
| Active Comparator: B<br>HRIG combined with rabies vaccination | Biological: HRIG<br>* HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28<br>|
| Placebo Comparator: C<br>Placebo combined with rabies vaccination | Biological: Placebo matching CL184<br>* Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies virus neutralizing activity |  | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rabies post-exposure prophylaxis