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

• Sponsor: Functional Genetics Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01299142
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 5.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Drug: FGI-101-1A6	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: Jul 1, 2011
• Anticipated Study Completion Date: Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety assessments [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

Secondary Outcome Measures

1. Pharmacokinetic analysis (PK) [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

2. Immunogenicity [From day 1 up to day 60 following infusion]

   Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	SNBL Clinical Pharmacology Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Functional Genetics Inc.
• United States Department of Defense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01299142
• Other Study ID Numbers: FGI-101-CP002; W911NF-11-C-0029
• First Posted: Feb 18, 2011
• Last Update Posted: Feb 18, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Influenza; antibodies; monoclonal; virus
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Feb 18, 2011