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
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedSeptember 21, 2011
September 1, 2011
4 months
April 4, 2008
September 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
42 days
Secondary Outcomes (1)
Rabies virus neutralizing activity
42 days
Study Arms (3)
A
EXPERIMENTALCL184 combined with rabies vaccination
B
ACTIVE COMPARATORHRIG combined with rabies vaccination
C
PLACEBO COMPARATORPlacebo combined with rabies vaccination
Interventions
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MDS Pharma Services , USA
Lincoln, Nebraska, 68502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C. James Kissling, MD
MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 10, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
September 21, 2011
Record last verified: 2011-09