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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00656097

Enrollment

140

Registered

2008-04-10

Start date

2008-03-31

Completion date

2008-07-31

Last updated

2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Keywords

Rabies post-exposure prophylaxis

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.

Interventions

BIOLOGICALCL184

CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

BIOLOGICALHRIG

HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

BIOLOGICALPlacebo matching CL184

Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	42 days

Secondary

Measure	Time frame
Rabies virus neutralizing activity	42 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026