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NCT01299142 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01299142
Other study ID # FGI-101-CP002
Secondary ID W911NF-11-C-0029
Status Recruiting
Phase Phase 1
First received February 16, 2011
Last updated February 16, 2011
Start date January 2011
Est. completion date October 2011

Study information
Verified date February 2011
Source Functional Genetics Inc.
Contact Melinda Roberson
Phone 410-706-8877
Email mroberson@snbl-pc.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date October 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy volunteers ages 18-45

- Normal laboratory (blood tests) results

Exclusion Criteria:

- Prior immunization with live-attenuated vaccines

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• FGI-101-1A6
anti-TSG101 human monoclonal antibody, single dose

Locations
Country Name City State
United States SNBL Clinical Pharmacology Center Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Functional Genetics Inc. United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 60 days following infusion Yes
Secondary 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 60 days following infusion No
Secondary Immunogenicity Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation From day 1 up to day 60 following infusion No
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