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

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FGI-101-1A6
Sponsored by
Functional Genetics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, antibodies, monoclonal, virus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior immunization with live-attenuated vaccines

Sites / Locations

  • SNBL Clinical Pharmacology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FGI-101-1A6

Placebo

Arm Description

Intervention: Drug-FGI-101-1A6

Intervention: Drug-Placebo

Outcomes

Primary Outcome Measures

Safety assessments
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)
PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6
Immunogenicity
Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation

Full Information

First Posted
February 16, 2011
Last Updated
February 16, 2011
Sponsor
Functional Genetics Inc.
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01299142
Brief Title
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
Official Title
Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Functional Genetics Inc.
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, antibodies, monoclonal, virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FGI-101-1A6
Arm Type
Experimental
Arm Description
Intervention: Drug-FGI-101-1A6
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Drug-Placebo
Intervention Type
Drug
Intervention Name(s)
FGI-101-1A6
Intervention Description
anti-TSG101 human monoclonal antibody, single dose
Primary Outcome Measure Information:
Title
Safety assessments
Description
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
Time Frame
60 days following infusion
Secondary Outcome Measure Information:
Title
Pharmacokinetic analysis (PK)
Description
PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6
Time Frame
60 days following infusion
Title
Immunogenicity
Description
Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation
Time Frame
From day 1 up to day 60 following infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers ages 18-45 Normal laboratory (blood tests) results Exclusion Criteria: Prior immunization with live-attenuated vaccines
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melinda Roberson
Phone
410-706-8877
Email
mroberson@snbl-pc.com
Facility Information:
Facility Name
SNBL Clinical Pharmacology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberson
Email
mroberson@snbl-pc.com
First Name & Middle Initial & Last Name & Degree
Mohammed Al-Ibrahim

12. IPD Sharing Statement

Learn more about this trial

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

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