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

Functional Genetics Inc.

Status and phase: Unknown; Phase 1

Conditions: Influenza

Treatments: Drug: FGI-101-1A6

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01299142

FGI-101-CP002

W911NF-11-C-0029 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Prior immunization with live-attenuated vaccines

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

FGI-101-1A6

Experimental group

Description:

Intervention: Drug-FGI-101-1A6

Treatment:

Drug: FGI-101-1A6

Placebo

Placebo Comparator group

Description:

Intervention: Drug-Placebo

Treatment:

Drug: FGI-101-1A6