Recruiting
Phase 1

FGI-101-1A6

Sponsor:

Functional Genetics Inc.

Code:

NCT01299142

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

FGI-101-1A6

Study Details

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.

Conditions

Influenza

Study ID

NCT01299142

Start date

Jan, 2011

Status verified date

Feb, 2011

Completion date

Oct, 2011

Anticipated

Primary completion date

Jul, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior immunization with live-attenuated vaccines

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: FGI-101-1A6

Intervention: Drug-FGI-101-1A6

placebo comparator: Placebo

Intervention: Drug-Placebo

Interventions

FGI-101-1A6

anti-TSG101 human monoclonal antibody, single dose

Primary outcome measure

  • Safety assessments [ Time Frame: 60 days following infusion ]

Central Contacts and Locations

Central contacts

Melinda Roberson

410-706-8877mroberson@snbl-pc.com

Locations

SNBL Clinical Pharmacology Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Roberson

mroberson@snbl-pc.com

Principal Investigator:

Mohammed Al-Ibrahim

More Information

Sponsor

Functional Genetics Inc.

Last update posted

Feb 18, 2011

Last verified

Feb, 2011

Keywords

  • Influenza
  • antibodies
  • monoclonal
  • virus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Functional Genetics Inc. on 2011-02-18.