Influenza, HumanPhase 1NCT01390025
Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza
A Phase 1 study testing TCN-032 in people with Influenza, Human, run by Theraclone Sciences, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety profile in healthy volunteers of a single intravenous administration of TCN-032 as compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- TCN-032
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2012
- 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
- Normal lab tests
Who cannot join
- Prior treatment with a monoclonal antibody
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
Official title: Phase 1 Study of TCN-032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Healthy Adult Volunteers
The purpose of this study is to compare the safety profile in healthy volunteers of a single intravenous administration of TCN-032 as compared with placebo.
Read the detailed description
Influenza is a highly communicable acute respiratory disease that is considered to be one of the major infectious disease threats to the human population. Annual vaccination is generally effective only against those strains included in the vaccine. Because of the frequent emergence of divergent variants and the periodic emergence of strains with novel hemagglutinin and/or neuraminidase surface proteins that can result in global pandemics, the availability of potent antiviral agents for the prevention and/or treatment of influenza remains an urgent clinical and public health priority.
- Conditions
- Influenza, Human
- Being tested
- TCN-032, Placebo
- Keywords
- Influenza, Monoclonal antibody
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCN-032Biological
TCN-032 is a human monoclonal antibody that specifically binds to a conserved epitope of the amino-terminal extracellular domain (M2e) of the influenza virus matrix protein 2 (M2). The drug is intended for use as an antiviral agent for the treatment of disease caused by type A influenza viruses. Treatments within the study will consist of single ascending dose-escalation ranging from 1 to 40 mg/kg.
PlaceboBiological
Placebo - 0.9% Sodium Chloride for Injection, USP
| Study group | Role | What they receive |
|---|---|---|
| TCN-032 | Experimental | Not described Receives: Biological: TCN-032 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment - number of participants with adverse events (AE)
Safety will be assessed by physical examinations, vital signs, serial electrocardiograms and clinical laboratory tests (hematology, chemistry and urinalysis). A clinically significant laboratory value will be any abnormal result that is an unexpected or unexplained laboratory value or change in value from the patient's prior values. AEs will be reported by severity and relatedness to study treatment and classified according to MedDRA
Measured: 60 days post infusion
Secondary outcomes (2)
Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032
PK evaluation of TCN-032 plasma concentrations will include: tmax (time at which maximum concentration is observed),Cmax (maximum observed concentration), t1/2 (terminal-elimination half-life), CL (clearance), Vd (volume of distribution).
Measured: 60 days post infusion
Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032
Immunogenicity will be assessed based on induction of TCN-032 anti-drug antibodies. Baseline and serial post-treatment serum measures of anti-TCN-032 antibodies will be detected by immunoassay and summarized by dose and time point with means, standard deviations, medians, quartiles, and ranges. Change from baseline in anti-TCN-032 antibody levels will be similarly analyzed.
Measured: 60 days post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclone Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MD, FACP, Principal investigator, SNBL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390025
- Sponsor's protocol ID
- TCN-032-001
- Status last verified
- Mar 2012
- First submitted
- 5 Jul 2011
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grandea AG 3rd, Olsen OA, Cox TC, Renshaw M, Hammond PW, Chan-Hui PY, Mitcham JL, Cieplak W, Stewart SM, Grantham ML, Pekosz A, Kiso M, Shinya K, Hatta M, Kawaoka Y, Moyle M. Human antibodies reveal a protective epitope that is highly conserved among human and nonhuman influenza A viruses. Proc Natl Acad Sci U S A. 2010 Jul 13;107(28):12658-63. doi: 10.1073/pnas.0911806107. Epub 2010 Jul 1.
PubMed 20615945
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of TCN-032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01390025
- Acronym / sponsor ID
- TCN-032-001
- Conditions
- Influenza, Human
- Keywords
- Influenza, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Theraclone Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Jul 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 compare the safety profile in healthy volunteers of a single intravenous administration of TCN-032 as compared with placebo.
Detailed description
Influenza is a highly communicable acute respiratory disease that is considered to be one of the major infectious disease threats to the human population. Annual vaccination is generally effective only against those strains included in the vaccine. Because of the frequent emergence of divergent variants and the periodic emergence of strains with novel hemagglutinin and/or neuraminidase surface proteins that can result in global pandemics, the availability of potent antiviral agents for the prevention and/or treatment of influenza remains an urgent clinical and public health priority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCN-032 | Experimental | Biological: TCN-032 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Normal lab tests
Key exclusion criteria (1 listed)
- Prior treatment with a monoclonal antibody
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 |
|---|---|---|
| TCN-032TCN-032 is a human monoclonal antibody that specifically binds to a conserved epitope of the amino-terminal extracellular domain (M2e) of the influenza virus matrix protein 2 (M2). The drug is intended for use as an antiviral agent for the treatment of disease caused by type A influenza viruses. Treatments within the study will consist of single ascending dose-escalation ranging from 1 to 40 mg/kg. | Biological | TCN-032 |
| PlaceboPlacebo - 0.9% Sodium Chloride for Injection, USP | Biological | Placebo |
Primary outcome
Safety assessment - number of participants with adverse events (AE)
Time frame: 60 days post infusion
Safety will be assessed by physical examinations, vital signs, serial electrocardiograms and clinical laboratory tests (hematology, chemistry and urinalysis). A clinically significant laboratory value will be any abnormal result that is an unexpected or unexplained laboratory value or change in value from the patient's prior values. AEs will be reported by severity and relatedness to study treatment and classified according to MedDRA
2 secondary outcomes
Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032
Time frame: 60 days post infusion
Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032
Time frame: 60 days post infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- Background: PubMed 20615945Grandea AG 3rd, Olsen OA, Cox TC, Renshaw M, Hammond PW, Chan-Hui PY, Mitcham JL, Cieplak W, Stewart SM, Grantham ML, Pekosz A, Kiso M, Shinya K, Hatta M, Kawaoka Y, Moyle M. Human antibodies reveal a protective epitope that is highly conserved among human and nonhuman influenza A viruses. Proc Natl Acad Sci U S A. 2010 Jul 13;107(28):12658-63. doi: 10.1073/pnas.0911806107. Epub 2010 Jul 1.
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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.
Mohamed Al-Ibrahim, MD, FACP principal investigator
SNBL
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 TCN-032 in people with Influenza, Human, run by Theraclone Sciences, 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: finished, as of the sponsor's last update on 2 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment - number of participants with adverse events (AE) (time frame: 60 days post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390025, which also lists 1 linked publication.
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 2 Apr 2012.