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

Crucell

Status and phase: Completed; Phase 2

Conditions: Rabies

Treatments: Biological: Placebo matching CL184; Biological: HRIG; Biological: CL184

Study type: Interventional

Funder types: Industry

Identifiers

NCT00656097

RAB-M-A003

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

CL184 combined with rabies vaccination

Treatment:

Biological: CL184

B

Active Comparator group

Description:

HRIG combined with rabies vaccination

Treatment:

Biological: HRIG

C

Placebo Comparator group

Description:

Placebo combined with rabies vaccination

Treatment:

Biological: Placebo matching CL184