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Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Functional Genetics Inc..
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
United States Department of Defense
Information provided by:
Functional Genetics Inc.
ClinicalTrials.gov Identifier:
NCT01299142
First received: February 16, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose
The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.

Condition Intervention Phase
Influenza
Drug: FGI-101-1A6
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers

Further study details as provided by Functional Genetics Inc.:

Primary Outcome Measures:
  • Safety assessments [ Time Frame: 60 days following infusion ] [ Designated as safety issue: Yes ]
    Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 60, or the early withdrawal, if applicable


Secondary Outcome Measures:
  • Pharmacokinetic analysis (PK) [ Time Frame: 60 days following infusion ] [ Designated as safety issue: No ]
    PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6

  • Immunogenicity [ Time Frame: From day 1 up to day 60 following infusion ] [ Designated as safety issue: No ]
    Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation


Estimated Enrollment: 48
Study Start Date: January 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FGI-101-1A6
Intervention: Drug-FGI-101-1A6
Drug: FGI-101-1A6
anti-TSG101 human monoclonal antibody, single dose
Placebo Comparator: Placebo
Intervention: Drug-Placebo
Drug: FGI-101-1A6
anti-TSG101 human monoclonal antibody, single dose

Detailed Description:

Primary -

- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as compared with Placebo

Secondary

  • To evaluate the pharmacokinetics (PK) of a singel intravenous administration of FGI-101-1A6
  • To evaluate the immunogenicity of FGI-101-1A6
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers ages 18-45
  • Normal laboratory (blood tests) results

Exclusion Criteria:

  • Prior immunization with live-attenuated vaccines
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299142

Locations
United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Functional Genetics Inc.
United States Department of Defense
  More Information

Responsible Party: Michael Goldblatt, CEO, Functional Genetics
ClinicalTrials.gov Identifier: NCT01299142     History of Changes
Other Study ID Numbers: FGI-101-CP002  W911NF-11-C-0029 
Study First Received: February 16, 2011
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Functional Genetics Inc.:
Influenza
antibodies
monoclonal
virus

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016