A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis

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Brief Title

A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis

Official Title

A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis

Brief Summary

      The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled
      asthma or bronchiectasis.
    

Detailed Description

      This study will assess the safety of a new study drug called DAS181 (Fludase®). This study is
      being done with NexBio, Inc., the company that makes DAS181 (Fludase®). DAS181 is not
      approved by the Food and Drug Administration (FDA); however the FDA has given permission to
      use DAS181 in human studies. To date, DAS181 has been given to about 81 healthy people and
      has been well tolerated with no reported serious adverse reactions. This is the first
      experimental study to test if it is safe to use this drug in people with well-controlled
      asthma or bronchiectasis. DAS181 is not being given to treat asthma or bronchiectasis, but to
      learn if it is safe to use in people with well-controlled asthma or bronchiectasis. DAS181 is
      being developed as a medication to prevent and treat infections due to common respiratory
      viruses like influenza (including the pandemic H1N1 strain), parainfluenza, and other
      viruses. New drugs to treat respiratory viruses are needed because some currently available
      drugs are not effective against some types or strains of viruses. Drugs that are effective
      against respiratory viruses are especially important for people with asthma or bronchiectasis
      because these lung conditions increase the risk of serious complications due to respiratory
      virus infections. Making sure the new drug is safe in people with asthma or bronchiectasis is
      important because people with these lung conditions may have different side effects from a
      drug than people who don't have asthma or bronchiectasis. We plan to enroll 24 volunteers
      into the study: 12 persons with well-controlled asthma and 12 persons with bronchiectasis.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and toxicity profile: Unacceptable Serious Adverse Events

Secondary Outcome

 Assessment of acute tolerability of DAS181 administration in subjects with well-controlled asthma or bronchiectasis, specifically with regard to airway obstruction (FEV1) and oxyhemoglobin saturation.

Condition

Asthma

Intervention

DAS181 dry powder, formulation F02

Study Arms / Comparison Groups

 DAS181 Dry Powder 10 mg qd x 3 days
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

11

Start Date

July 2010

Completion Date

August 22, 2011

Primary Completion Date

August 22, 2011

Eligibility Criteria

        Inclusion Criteria:

          1. A male or female subject must be 18 to 65 years of age.

          2. Except for underlying airway disease, subject must be in good health as determined by
             medical history, targeted physical examination based on medical history, and vital
             signs (that include temperature, blood pressure, heart rate, and pulse oximetry).

          3. Subject must be able to verbalize understanding of the informed consent form,
             verbalize willingness to complete all study procedures, and provide written informed
             consent (sign the informed consent form).

          4. Subject must be willing to commit to participating in both the initial and cross-over
             stages of the study.

          5. Dipstick analysis of subject's urine specimen must be negative or show only trace
             amounts of glucose, hemoglobin, and protein. A menstruating female who tests positive
             for urine hemoglobin may be retested.

          6. Subject must have blood screening test results that are within normal limits
             (according to standards set within the Clinical Center) for the following tests:
             alanine transaminase (ALT), alkaline phosphatase (ALKP), activated partial
             thromboplastin time (APTT), and aspartate transaminase (AST).

          7. Subject must have hematologic screening tests that are within a specified range,
             including hemoglobin of 10.9 g/dL, white blood cell count 2500/mm3, and platelet count
             125,000/mm3 (all 24 hour) worsening
             of >3 respiratory symptoms associated with bacterial infection including: i. Cough ii.
             Dyspnea iii. Hemoptysis iv. Increased sputum purulence or volume v. Chest pain b. No
             change in antimicrobial regimen for at least 3 months before enrollment c. FEV1 80%
             predicted d. Use of short-acting beta-agonist 2 days/week for at least the past 3
             months e. No baseline requirement for oxygen supplementation f. Ability to maintain
             oxyhemoglobin saturation of 90% during and after 6-minute walk test g. Not currently
             taking oral corticosteroids

        Exclusion Criteria:

          1. Subject has received any investigational drug or vaccine within 4 weeks prior to study
             drug dosing, or is planning to participate in another investigational drug or vaccine
             trial prior to completion of this study.

          2. Subject is currently taking theophylline or oral corticosteroids.

          3. Subject is allergic to milk or milk products.

          4. Subject currently smokes tobacco or has smoked tobacco within 1 year prior to study
             enrollment.

          5. Subject has a baseline requirement for oxygen supplementation.

          6. Subject is unable to maintain an oxyhemoglobin saturation of 90% during and after
             6-minute walk test.

          7. The subject tests positive for human immunodeficiency virus (HIV), for hepatitis B
             virus (HBV), or hepatitis C virus (HCV).

          8. The subject's resting blood pressure is outside normal limits (defined as: systolic
             90-140 mmHg; diastolic 50-90 mm Hg).

          9. The subject's heart rate is less than 45 or greater than 100 beats per minute at rest.

         10. The subject weighs less than 45 kg.

         11. The subject has a Body Mass Index of greater than 35 kg/m2.

         12. The subject has experienced an episode of acute upper respiratory tract infection,
             pneumonia, otitis, bronchitis, or sinusitis within 6 weeks of study enrollment.

         13. The subject has an oral temperature above 37.8°C (100°F).

         14. The subject has 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.

         15. The subject has overt primary ciliary dyskinesia, allergic bronchopulmonary
             aspergillosis, or cystic fibrosis.

         16. The subject has previous or current history of the following conditions: renal,
             hepatic, cardiac, hematologic (including sickle cell disease), muscular, neurological,
             metabolic, or immunological disorders, malignancy, hepatitis or cirrhosis, transplant
             recipients, HIV-infection, or other immunosuppressive illness, which could, in the
             opinion of the study investigators, compromise subject safety or interfere with the
             assessment of study drug safety.

         17. A female who is pregnant or breast-feeding.

         18. A subject who has received blood products within 6 months of study enrollment.

         19. The subject has donated or lost more than 500 mL of blood in the 3 months prior to
             screening.

         20. The subject has clinically significant medical or psychological conditions that would
             compromise the subject's safety, influence the results of the study, affect the
             subject's ability to participate in the study, or impair the subject's ability to
             provide informed consent.

         21. The subject has a history of alcoholism, drug dependence, or significant psychiatric
             illness within 2 years of study enrollment.

         22. The subject uses anticoagulant medications or drugs with known potential for
             hepatotoxicity as such agents could interfere with relevant safety assessments.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ronald Moss, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01113034

Organization ID

DAS181 - 1 - 04, 10 - I - 0085


Responsible Party

Sponsor

Study Sponsor

Ansun Biopharma, Inc.

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Ronald Moss, MD, Study Director, Ansun Biopharma, Inc.


Verification Date

July 2010