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InfluenzaPhase 1NCT01747148

Testing the AVI-7100 Flu Drug in Healthy Volunteers

A Phase 1 study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes only a mild illness, but some people can become seriously ill or even die from it. Currently, some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms end about a day sooner. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Influenza
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteUnited States
Study dates
8 Dec 2012to 29 Jun 2016
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age greater than or equal to 18 years and less than or equal to 60 years
  • Body mass index (BMI) of 19-32 kg/m(2)
  • Estimated glomerular filtration rate greater than or equal to 90 mL/min at screening, calculated using the MDRD formula
  • Subjects must agree to:
  • Not take any prescription or OTC medications with the exception of Tylenol, vitamins, seasonal allergy medications, and/or contraceptive medications for a period 7 days prior and during study drug administration.
  • Not consume any alcohol for a period 2 days prior to and during study drug administration.
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  • 5. One of the following in order to avoid pregnancy:
  • Females who are able to become pregnant (i.e., are not postmenopausal)
  • have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception.
  • From the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug. At least one of the methods of contraception should be a barrier method.
  • Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug.

Who cannot join

  • Any chronic medical problem that requires daily oral medications (except Tylenol, oral contraceptives, vitamins, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a phase I drug.
  • History of cardiovascular disease or unexplained syncope
  • Women who are breast-feeding.
  • Positive urine or serum pregnancy test.
  • Abnormal ECG
  • -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table.
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  • --evaluating PR interval, QTc interval and rhythm.
  • Abnormal chemistry panel
  • -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
  • --evaluating only sodium [Na], potassium [K], serum bicarbonate [total CO2], creatinine, glucose,albumin, ALT, AST, ALKP, GGT, total bilirubin, LDH, and estimated GFR by the MDRD equation.
  • Abnormal complete blood count (CBC)
  • -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
  • -- evaluating only the WBC (to include absolute neutrophil and lymphocyte counts), hemoglobin, hematocrit, and platelets.
  • Abnormal urinalysis
  • -defined as any clinically significant baseline Grade 1 or greater toxicity
  • --evaluating only protein, and RBCs.
  • Urine-albumin-to-creatinine ratio (UACR) >30 mg/g.
  • Positive serology for Hepatitis B surface antigen.
  • Positive serology for Hepatitis C.
  • Positive serology for HIV-1.
  • Positive urine drug screen.
  • Participation in a study with receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study drug administration (i.e., Day 0)
  • Donation of blood or blood products within 30 days or plasma within 2 weeks prior to study drug administration (i.e., Day 0)
  • Receipt of blood products within 2 months prior to study drug administration (i.e., Day 0)
  • Receipt of any vaccination within 30 days prior to study drug administration (i.e., Day 0)
  • Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject s ability to complete and/or participate in this clinical study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects

Background:

  • Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes only a mild illness, but some people can become seriously ill or even die from it. Currently, some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms end about a day sooner. More treatment choices for the flu are needed, especially for those who become seriously ill. Researchers want to test a new drug, AVI-7100, that might keep a person who takes it from having a more serious case of the flu.
Read more

Objectives:

  • To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug.

Eligibility:

  • Healthy volunteers of normal weight between 18 and 60 years of age.

Design:

  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. A heart function test will also be performed.
  • Participants will have either AVI-7100 or a placebo infusion. They will not know which infusion they have. . Participants will stay at the clinical center for a total of 8 hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after the end of the infusion
  • Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood and urine samples will be collected. A heart function test will also be performed.
  • There will be a second part of the study that is separate from the first one. Additional people will receive either AVI-7100 or placebo to test their reactions to a specific dose.
Read the detailed description

Despite currently available antivirals, influenza causes significant morbidity and mortality (estimated 36,000 deaths each year in the United States alone). More agents are needed in the armamentarium of anti-influenza medications including novel mechanisms of action and parenteral agents.

This study will evaluate the safety of a novel RNA based therapeutic AVI-7100. Beginning with a low single-dose, subjects are randomized to receive either AVI-7100 or placebo and evaluated on Study Days 0, 1, 2, 4, 10, 28. The safety and tolerability is evaluated using symptoms, clinical laboratory tests, ECG, and pharmacokinetics. Utilizing a series of stopping rules and a medical monitor, the dose will be escalated as safety and tolerability are established. Once the maximum tolerated dose (MTD) is established in the first part of this study (either limited by adverse effects or up to maximum anticipated dose), the safety and tolerability of multi-dose administration will begin (replicating anticipated clinical use). Subjects again are randomized to either AVI-7100 or placebo daily for 5 days, and evaluated on Study Days 0, 1, 2, 3, 4, 5, 6, 8, 14, and 32. The dose used in the multi-dose cohorts will also be escalated as safety and tolerability are established.

Conditions
Influenza
Being tested
AVI-7100 versus placebo
Keywords
Antisense, Influenza, IV Injection, RNA Based Therapeutic, RNA Interference
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-7100 versus placeboDrug

    dose-escalating AVI-7100 versus placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety and tolerability of AVI-7100 in healthy adults, following single- or multiple-dose, intravenous administration at escalating dose-levels

    Measured: 2 years

Secondary outcomes (1)

  1. To evaluate the pharmacokinetics of intravenously administered AVI-7100 in healthy adults, following single- or multiple-dose, intravenous administration at escalating dose-levels

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2012 (estimated)
  2. Study start8 Dec 2012
  3. Primary completion29 Jun 2016
  4. Study completion29 Jun 2016

Resources

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
Single group
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01747148
Sponsor's protocol ID
130029
Other IDs
13-I-0029
Status last verified
21 Dec 2017
First submitted
8 Dec 2012
Last updated
26 Dec 2017
Results posted
No

Publications

  • Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.

    PubMed 19423869

  • Abe T, Mizuta T, Hatta T, Miyano-Kurosaki N, Fujiwara M, Takai K, Shigeta S, Yokota T, Takaku H. Antisense therapy of influenza. Eur J Pharm Sci. 2001 Apr;13(1):61-9. doi: 10.1016/s0928-0987(00)00208-6.

    PubMed 11292569

  • Mizuta T, Fujiwara M, Abe T, Miyano-Kurosaki N, Yokota T, Shigeta S, Takaku H. Inhibitory effects of an antisense oligonucleotide in an experimentally infected mouse model of influenza A virus. Biochem Biophys Res Commun. 2000 Dec 9;279(1):158-61. doi: 10.1006/bbrc.2000.3924.

    PubMed 11112432

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 11 inclusion and 26 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 26 Dec 2017. 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 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?

To evaluate the safety and tolerability of AVI-7100 in healthy adults, following single- or multiple-dose, intravenous administration at escalating dose-levels (time frame: 2 years). 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 NCT01747148, which also lists 3 linked publications.

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 26 Dec 2017.

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