Baltimore, Maryland 21201


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.


Study summary:

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


Criteria:

Inclusion Criteria: - Healthy volunteers ages 18-45 - Normal laboratory (blood tests) results Exclusion Criteria: - Prior immunization with live-attenuated vaccines


Study is Available At:


Original ID:

FGI-101-CP002


NCT ID:

NCT01299142


Secondary ID:

W911NF-11-C-0029


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Functional Genetics Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

48


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:January 2011
Completion Date:October 2011
Completion Type:Anticipated
Primary Completion Date:July 2011
Primary Completion Type:Anticipated
Verification Date:February 2011
Last Changed Date:February 16, 2011
First Received Date:February 16, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Immunogenicity
Time Frame:From day 1 up to day 60 following infusion
Safety Issues:False
Description:Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation
Outcome Type:Secondary Outcome
Measure:Pharmacokinetic analysis (PK)
Time Frame:60 days following infusion
Safety Issues:False
Description:PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6
Outcome Type:Primary Outcome
Measure:Safety assessments
Time Frame:60 days following infusion
Safety Issues:True
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

Study Interventions

Intervention Type:Drug
Name:FGI-101-1A6
Description:anti-TSG101 human monoclonal antibody, single dose
Arm Name:FGI-101-1A6

Study Arms

Study Arm Type:Experimental
Arm Name:FGI-101-1A6
Description:Intervention: Drug-FGI-101-1A6
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Intervention: Drug-Placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Functional Genetics Inc.
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Department of Defense

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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