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InfluenzaPhase 2NCT01037205

Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza

A Phase 2 study testing DAS181 dry powder, formulation F02 and Respitose ML006 (DMV-Fonterra) in people with Influenza, run by Ansun Biopharma, Inc. at 42 sites 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

This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Influenza
What is being tested?
DAS181 dry powder, formulation F02 and Respitose ML006 (DMV-Fonterra)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
42 sitesUnited States
Study dates
Dec 2009to Sep 2011
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a targeted physical exam based on medical history.
  • Subjects must be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures.
  • Be 18 to 70 years of age (inclusive).
  • Subjects must weigh at least 55 kg and must have a Body Mass Index (BMI) of no greater than 35.99
  • Febrile, oral temperature >100°F (37.8°C) and one or more of the following:
  • Respiratory symptom (cough, sore throat, nasal symptoms)
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  • Constitutional symptom (headache, myalgia, sweat/chills, prostration)
  • Positive rapid antigen test (RAT) for influenza performed using FDA-Cleared and CLIA-Waived commercially available rapid antigen test. A subject may be enrolled following a positive RAT of any manufacturer. Test may be conducted by a primary care physician prior to study enrollment if documentation of a positive RAT can be provided (documentation may consist of subjects medical records and must be included in subject documentation). A subject with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community. Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute.
  • Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute.
  • Onset of illness no more than 48 hours prior to diagnosis. Note: Time of onset of illness is defined as either (1) the time when the temperature was first measured as elevated (at least one degree (°C) of elevation temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom or the presence of at least one constitutional symptom.
  • Female subjects must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, practicing abstinence or practicing two effective methods of birth control. Acceptable methods may include intrauterine device, spermicide, barrier and hormonal contraception. A female subject must agree to practice an acceptable method of birth control during study period and for 12 weeks after study terminates. All female subjects regardless of menopausal status or surgical history must have had a negative urine pregnancy test (urine betahuman chorionic gonadotropin [hCG]) during the screening visit. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG.
  • Male subjects must agree to use a medically accepted form of contraception from time of enrollment to 12 weeks after study termination.

Who cannot join

  • Have received any investigational drug or vaccine within 8 weeks prior to study drug dosing.
  • Have had a serious adverse reaction or hypersensitivity to any drug.
  • Have received blood products within 6 months of study enrollment.
  • Have concurrent cystic fibrosis, emphysema or previous episodes of anaphylaxis.
  • Have sickle-cell disease.
  • Allergy or history of allergy to milk or lactose.
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  • Any history of congenital or acquired bleeding abnormalities.
  • Existence of any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
  • Use of antiviral influenza medications within 10 days prior to screening (subjects will be prohibited from taking antiviral influenza medications during the course of the trial).
  • Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening.
  • Known hypersensitivity to DAS181.
  • Women who are pregnant (urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding.
  • Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study participation.
  • Any significant findings in the subject's medical history or physical examination that, in the opinion of the investigator, would affect subject safety or compliance with the dosing schedule.
  • Documented infection other than IFV in past 2 weeks.
  • Subjects with previous or current history of asthma or COPD requiring acute or chronic medication.
  • Subjects with acute diagnosis of a chronic medical condition within the last 3 months.
  • Subjects with a chronic medical condition that have initiated or changed dosing or regimen of prescription medications for their chronic medical condition within the last 3 months (any changes in chronic medications during the 28 day enrollment period will be captured in the source documentation under concomitant medications).
  • Subjects with previous or current history of the following systemic disorders: immunological disorders, HBV, HCV or cirrhosis, transplant recipients, HIV infection, or other immunosuppressive illness.
  • Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic diseases excluding noninvasive basal cell carcinoma.
  • Subjects who have had or are scheduled to have surgery within 30 days of initiation of the study.
  • Subjects who have donated or lost more than 500 mL of blood in the two months prior to screening.
  • Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Study site

    Ashland, Oregon

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bellevue, Nebraska

  • Study site

    Boise, Idaho

  • Study site

    Canton, Ohio

  • Study site

    Carmichael, California

  • Study site

    Chula Vista, California

  • Study site

    Colorado Springs, Colorado

  • Study site

    Covington, Louisiana

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Franklin, Ohio

  • Study site

    Georgetown, Texas

  • Study site

    Groveport, Ohio

  • Study site

    Henderson, Nevada

  • Study site

    Hialeah, Florida

  • Study site

    Johnson City, Tennessee

  • Study site

    La Mesa, California

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, California

  • Study site

    Los Angeles, California

  • Study site

    Miami, Florida

  • Study site

    Miamisburg, Ohio

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    North Dartmouth, Massachusetts

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Rapid City, South Dakota

  • Study site

    Richmond, Virginia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Silver Spring, Maryland

  • Study site

    Simpsonville, South Carolina

  • Study site

    Stony Brook, New York

  • Study site

    Tampa, Florida

  • Study site

    Tulsa, Oklahoma

  • Study site

    West Point, Utah

  • Study site

    West Valley City, Utah

Other trials in United States

About this study

This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).

Read the detailed description

This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).

Based upon a Rapid Diagnostic Test of IFV, subjects will be randomized into one of three groups: a single dose DAS181 10 mg group, a multiple dose DAS181 10 mg, 10 mg, 10 mg dose group or a placebo group.

The full analysis set will include subjects with confirmed influenza as documented with Rapid Diagnostic Testing. The set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Study staff may visit subjects outside the clinic. Per protocol, the safety analysis sets are described below in Statistical Methods.

Peripheral venous blood samples for pharmacokinetic (PK) and immunogenic analysis of DAS181 will be obtained on 10 subjects enrolled in each study arm.

Conditions
Influenza
Being tested
DAS181 dry powder, formulation F02, Respitose ML006 (DMV-Fonterra)
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DAS181 dry powder, formulation F02Drug

    10 mg delivered dose DAS181 in clear HPMC #3 Capsules

  • Respitose ML006 (DMV-Fonterra)Drug

    Lactose monohydrate

Study groups in NCT01037205
Study groupRoleWhat they receive
DAS181 High DoseActive comparatorDAS181 Dry Powder 10 mg qd x 3 days
Receives: Drug: DAS181 dry powder, formulation F02
DAS181 Low DoseActive comparatorDAS181 Dry Powder 10 mg Day 1 Lactose Placebo Day 2 and Day 3
Receives: Drug: DAS181 dry powder, formulation F02
Lactose PlaceboPlacebo comparatorLactose (Respitose ML006 (DMV-Fonterra)) 1 capsule qd x 3 days
Receives: Drug: Respitose ML006 (DMV-Fonterra)

What is being measured

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

  1. Level of influenza viral load as Area Under the Curve at Day 5 (AUC0 d5) as measured by a) quantitative polymerase chain reaction (quantitative PCR) and b) 50% tissue culture infectious dose (TCID50) in cell culture

    Measured: 28 days

  2. Safety and toxicity profile: Unacceptable Serious Adverse Events

    Measured: 28 days

Timeline

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

  1. First posted22 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionSep 2011
  4. Study completionSep 2011

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01037205
Sponsor's protocol ID
DAS181 - 2 - 03 (DMID 09-0090)
Other IDs
HHSN266200600015C
Status last verified
Jul 2013
First submitted
18 Dec 2009
Last updated
8 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Moss RB, Hansen C, Sanders RL, Hawley S, Li T, Steigbigel RT. A phase II study of DAS181, a novel host directed antiviral for the treatment of influenza infection. J Infect Dis. 2012 Dec 15;206(12):1844-51. doi: 10.1093/infdis/jis622. Epub 2012 Oct 8.

    PubMed 23045618

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DAS181 dry powder, formulation F02 and Respitose ML006 (DMV-Fonterra) in people with Influenza, run by Ansun Biopharma, Inc. at 42 sites 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 12 inclusion and 23 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Level of influenza viral load as Area Under the Curve at Day 5 (AUC0 d5) as measured by a) quantitative polymerase chain reaction (quantitative PCR) and b) 50% tissue culture infectious dose (TCID50) in cell culture (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT01037205, 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 8 Apr 2014.

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