InfluenzaPhase 1NCT01375985
Safety Study of Single Administration Intravenous Treatment for Influenza
A Phase 1 study testing AVI-7100 in people with Influenza, run by Sarepta Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-7100, a candidate treatment for influenza. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- AVI-7100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female and between the ages of 18 and 50 years in good general health
- Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
- Volunteers must be willing to undergo a urine screen for drugs of abuse
Who cannot join
- Pregnancy or breastfeeding.
- Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
- Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects
The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-7100, a candidate treatment for influenza.
Read the detailed description
Influenza A, a member of the Orthomyxoviridae family, is composed of a negative-sense,single-stranded and segmented ribonucleic acid (RNA) genome. An urgent need exists for new forms of treatment for influenza A based on (a) the known propensity of this virus to undergo both continuous low-level antigenic drift and less frequent but unpredictable major antigenic shift leading to pandemic disease, (b) the clear failure of vaccination, even when strains are reasonably matched, to prevent influenza-related illness in a significant proportion of vaccine recipients, and (c) the increased frequency of resistance to approved forms of therapy for influenza (eg, the adamantane derivatives and, more recently, the NA inhibitor, oseltamivir). AVI-7100 is an experimental phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). AVI-7100 specifically targets viral messenger RNA sequences. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-7100 in healthy human subjects.
- Conditions
- Influenza
- Being tested
- AVI-7100, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVI-7100Drug
Single intravenous administration
PlaceboDrug
Single intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| AVI-7100 | Experimental | Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™) Receives: Drug: AVI-7100 |
| Placebo | Experimental | Vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing adverse events
Measured: 28 days
Secondary outcomes (2)
Plasma drug concentration
Measured: 28 days
Urine drug concentration
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionNov 2011
Why it stopped: The study was halted after enrollment of the first cohort because of lack of funding
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.
- More trials run by Sarepta Therapeutics, Inc.The sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarepta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Hale, MD, Principal investigator, Covance Clinical Research UnitAlison Heald, MD, Study director, Sarepta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375985
- Sponsor's protocol ID
- 7100-us-101
- Status last verified
- Jun 2013
- First submitted
- 16 Jun 2011
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01375985
- Acronym / sponsor ID
- 7100-us-101
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted after enrollment of the first cohort because of lack of funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sarepta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Jun 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 characterize the safety and pharmacology of single administrations of AVI-7100, a candidate treatment for influenza.
Detailed description
Influenza A, a member of the Orthomyxoviridae family, is composed of a negative-sense,single-stranded and segmented ribonucleic acid (RNA) genome. An urgent need exists for new forms of treatment for influenza A based on (a) the known propensity of this virus to undergo both continuous low-level antigenic drift and less frequent but unpredictable major antigenic shift leading to pandemic disease, (b) the clear failure of vaccination, even when strains are reasonably matched, to prevent influenza-related illness in a significant proportion of vaccine recipients, and (c) the increased frequency of resistance to approved forms of therapy for influenza (eg, the adamantane derivatives and, more recently, the NA inhibitor, oseltamivir). AVI-7100 is an experimental phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). AVI-7100 specifically targets viral messenger RNA sequences. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-7100 in healthy human subjects.
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 |
|---|---|---|
| AVI-7100 | Experimental | Drug: AVI-7100Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™) |
| Placebo | Experimental | Drug: PlaceboVehicle |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female and between the ages of 18 and 50 years in good general health
- Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
- Volunteers must be willing to undergo a urine screen for drugs of abuse
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding.
- Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
- Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection
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 |
|---|---|---|
| AVI-7100Single intravenous administration | Drug | AVI-7100 |
| PlaceboSingle intravenous administration | Drug | Placebo |
Primary outcome
Number of subjects experiencing adverse events
Time frame: 28 days
2 secondary outcomes
Plasma drug concentration
Time frame: 28 days
Urine drug concentration
Time frame: 28 days
Results and safety
The study was stopped early (reason given: The study was halted after enrollment of the first cohort because of lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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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.
Christine Hale, MD principal investigator
Covance Clinical Research Unit
Alison Heald, MD study director
Sarepta Therapeutics, Inc.
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 AVI-7100 in people with Influenza, run by Sarepta Therapeutics, 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Jun 2013. 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. 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 was stopped early (reason given: The study was halted after enrollment of the first cohort because of lack of funding). Results are not available in the source record.
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?
Number of subjects experiencing adverse events (time frame: 28 days). 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 11 Jun 2013.