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

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ClinicalTrials.gov Identifier: NCT01299142
Recruitment Status : Unknown
Verified February 2011 by Functional Genetics Inc..
Recruitment status was:  Recruiting
First Posted : February 18, 2011
Last Update Posted : February 18, 2011
United States Department of Defense
Information provided by:
Functional Genetics Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Drug: FGI-101-1A6 Phase 1

Detailed Description:

Primary -

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


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : October 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior immunization with live-attenuated vaccines

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

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

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

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 Posted: February 18, 2011    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011

Keywords provided by Functional Genetics Inc.:

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