Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza
2 other identifiers
interventional
264
1 country
42
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
December 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedApril 8, 2014
July 1, 2013
1.8 years
December 18, 2009
April 5, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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
28 days
Safety and toxicity profile: Unacceptable Serious Adverse Events
28 days
Study Arms (3)
DAS181 High Dose
ACTIVE COMPARATORDAS181 Dry Powder 10 mg qd x 3 days
DAS181 Low Dose
ACTIVE COMPARATORDAS181 Dry Powder 10 mg Day 1 Lactose Placebo Day 2 and Day 3
Lactose Placebo
PLACEBO COMPARATORLactose (Respitose ML006 (DMV-Fonterra)) 1 capsule qd x 3 days
Interventions
10 mg delivered dose DAS181 in clear HPMC #3 Capsules
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ansun Biopharma, Inc.lead
- National Institutes of Health (NIH)collaborator
Study Sites (42)
Unknown Facility
Carmichael, California, United States
Unknown Facility
Chula Vista, California, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Lincoln, California, United States
Unknown Facility
Los Angeles, California, United States
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Orange, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Boise, Idaho, United States
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Covington, Louisiana, United States
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Silver Spring, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Bellevue, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Stony Brook, New York, United States
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Canton, Ohio, United States
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Dayton, Ohio, United States
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Franklin, Ohio, United States
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Groveport, Ohio, United States
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Miamisburg, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Ashland, Oregon, United States
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Lansdale, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Myrtle Beach, South Carolina, United States
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Simpsonville, South Carolina, United States
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Rapid City, South Dakota, United States
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Johnson City, Tennessee, United States
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Austin, Texas, United States
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Georgetown, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
Unknown Facility
West Point, Utah, United States
Unknown Facility
West Valley City, Utah, United States
Unknown Facility
Richmond, Virginia, United States
Related Publications (1)
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.
PMID: 23045618DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ronald Moss, MD
Ansun Biopharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2009
First Posted
December 22, 2009
Study Start
December 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
April 8, 2014
Record last verified: 2013-07