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

Phase 2

Completed

• Conditions: Rabies
• Interventions: Biological: CL184; Biological: HRIG; Biological: Placebo matching CL184

• Registration Number: NCT00656097
• Lead Sponsor: Crucell Holland BV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Disposition First Submitted: 2009-06-24
• Disposition First Submitted QC: 2009-07-31
• Disposition First Posted: 2009-08-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-15
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	CL184	CL184 combined with rabies vaccination
B	HRIG	HRIG combined with rabies vaccination
C	Placebo matching CL184	Placebo combined with rabies vaccination

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	42 days

Secondary Outcome Measures

Name	Time	Method
Rabies virus neutralizing activity	42 days

Trial Locations

Locations (1)

MDS Pharma Services , USA; 🇺🇸 Lincoln, Nebraska, United States