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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Functional Genetics Inc..
Recruitment status was  Recruiting
Department of Defense
Information provided by:
Functional Genetics Inc. Identifier:
First received: February 16, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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
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


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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01299142

Contact: Melinda Roberson 410-706-8877

United States, Maryland
SNBL Clinical Pharmacology Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Roberson   
Principal Investigator: Mohammed Al-Ibrahim         
Sponsors and Collaborators
Functional Genetics Inc.
Department of Defense
  More Information

No publications provided

Responsible Party: Michael Goldblatt, CEO, Functional Genetics 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.:

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015