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

February 16, 2011 updated by: Functional Genetics Inc.

Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • SNBL Clinical Pharmacology Center
        • Contact:
        • Principal Investigator:
          • Mohammed Al-Ibrahim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior immunization with live-attenuated vaccines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 days following infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 days following infusion
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
From day 1 up to day 60 following infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Functional Genetics Inc.

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGI-101-CP002
  • W911NF-11-C-0029 (Other Grant/Funding Number: W911NF-11-C-0029)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on FGI-101-1A6

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe