InfluenzaPhase 1NCT01299142
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
A Phase 1 study testing FGI-101-1A6 in people with Influenza, run by Functional Genetics Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FGI-101-1A6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers ages 18-45
- Normal laboratory (blood tests) results
Who cannot join
- Prior immunization with live-attenuated vaccines
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
Roberson, mroberson@snbl-pc.com
Mohammed Al-Ibrahim
About this study
Official title: Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers
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.
Read the 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
- Conditions
- Influenza
- Being tested
- FGI-101-1A6
- Keywords
- Influenza, antibodies, monoclonal, virus
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGI-101-1A6Drug
anti-TSG101 human monoclonal antibody, single dose
| Study group | Role | What they receive |
|---|---|---|
| FGI-101-1A6 | Experimental | Intervention: Drug-FGI-101-1A6 Receives: Drug: FGI-101-1A6 |
| Placebo | Placebo comparator | Intervention: Drug-Placebo Receives: Drug: FGI-101-1A6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments
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
Measured: 60 days following infusion
Secondary outcomes (2)
Pharmacokinetic analysis (PK)
PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6
Measured: 60 days following infusion
Immunogenicity
Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation
Measured: From day 1 up to day 60 following infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Functional Genetics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299142
- Sponsor's protocol ID
- FGI-101-CP002
- Other IDs
- W911NF-11-C-0029
- Status last verified
- Feb 2011
- First submitted
- 16 Feb 2011
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01299142
- Acronym / sponsor ID
- FGI-101-CP002
- Conditions
- Influenza
- Keywords
- Influenza, antibodies, monoclonal, virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Functional Genetics Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGI-101-1A6 | Experimental | Drug: FGI-101-1A6Intervention: Drug-FGI-101-1A6 |
| Placebo | Placebo comparator | Drug: FGI-101-1A6Intervention: Drug-Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers ages 18-45
- Normal laboratory (blood tests) results
Key exclusion criteria (1 listed)
- Prior immunization with live-attenuated vaccines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FGI-101-1A6anti-TSG101 human monoclonal antibody, single dose | Drug | FGI-101-1A6, Placebo |
Primary outcome
Safety assessments
Time frame: 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
2 secondary outcomes
Pharmacokinetic analysis (PK)
Time frame: 60 days following infusion
Immunogenicity
Time frame: From day 1 up to day 60 following infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FGI-101-1A6 in people with Influenza, run by Functional Genetics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melinda Roberson (410-706-8877, mroberson@snbl-pc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessments (time frame: 60 days following infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.