We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01299142
First Posted: February 18, 2011
Last Update Posted: February 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by:
Functional Genetics Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299142


Contacts
Contact: Melinda Roberson 410-706-8877 mroberson@snbl-pc.com

Locations
United States, Maryland
SNBL Clinical Pharmacology Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Roberson       mroberson@snbl-pc.com   
Principal Investigator: Mohammed Al-Ibrahim         
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 ( Other Grant/Funding Number: W911NF-11-C-0029 )
First Submitted: February 16, 2011
First Posted: February 18, 2011
Last Update Posted: February 18, 2011
Last Verified: February 2011

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

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