Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Functional Genetics Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Functional Genetics Inc.
Collaborator:
Information provided by:
Functional Genetics Inc.
ClinicalTrials.gov Identifier:
NCT01299142
First received: February 16, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Influenza |
Drug: FGI-101-1A6 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Functional Genetics Inc.:
Primary Outcome Measures:
- Safety assessments [ Time Frame: 60 days following infusion ] [ Designated as safety issue: Yes ]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:
- Pharmacokinetic analysis (PK) [ Time Frame: 60 days following infusion ] [ Designated as safety issue: No ]PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6
- Immunogenicity [ Time Frame: From day 1 up to day 60 following infusion ] [ Designated as safety issue: No ]Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers ages 18-45
- Normal laboratory (blood tests) results
Exclusion Criteria:
- Prior immunization with live-attenuated vaccines
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299142
Contacts
| Contact: Melinda Roberson | 410-706-8877 | mroberson@snbl-pc.com |
Locations
| United States, Maryland | |
| SNBL Clinical Pharmacology Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Roberson mroberson@snbl-pc.com | |
| Principal Investigator: Mohammed Al-Ibrahim | |
Sponsors and Collaborators
Functional Genetics Inc.
More Information
No publications provided
| Responsible Party: | Michael Goldblatt, CEO, Functional Genetics |
| ClinicalTrials.gov Identifier: | NCT01299142 History of Changes |
| Other Study ID Numbers: | FGI-101-CP002, W911NF-11-C-0029 |
| Study First Received: | February 16, 2011 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Functional Genetics Inc.:
|
Influenza antibodies monoclonal virus |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013