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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01299142

Enrollment

Registered

2011-02-18

Start date

2011-01-31

Completion date

2011-10-31

Last updated

2011-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, antibodies, monoclonal, virus

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.

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

Interventions

DRUGFGI-101-1A6

anti-TSG101 human monoclonal antibody, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Prior immunization with live-attenuated vaccines

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Immunogenicity	From day 1 up to day 60 following infusion	Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation

Countries

United States

Contacts

Primary ContactMelinda Roberson

mroberson@snbl-pc.com410-706-8877

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026