Single Dose Escalating Study of DAS181 in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and systemic exposure of an experimental
      influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is
      administered via oral inhalation using a special device. Study participants will include up
      to 60 healthy, non-smoking males and females, ages 18-65. They will be given either DAS181 or
      placebo. Participants will remain in the clinic overnight to be watched for health changes
      for 24 hours after receiving the medication. Study procedures include: physical exams, chest
      x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs.
      Follow-up visits will occur on study days 2, 7, 14 +/- 1 day, and 30 +/- 2 days. Participants
      will be involved in the study for up to 61 days, which includes the screening period.
    

Detailed description: 
      The objective of this study is to investigate the safety, tolerability and pharmacokinetics
      of a single dose of DAS181 encapsulated dry powder compared to placebo when administered by
      oral inhalation using a dry powder inhaler in healthy adults. Primary study outcome measures
      are the safety and tolerability of single-dose DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg,
      and 4.5 mg, as measured in the following parameters: adverse events, physical exam, vital
      signs, hematology, clinical chemistry, blood coagulation, complement activation, haptoglobin
      and immunogenicity, urinalysis, throat swab for bacterial culture, ECG, chest X-ray, and
      spirometric lung function. Secondary outcome measures are the systemic exposure and
      pharmacokinetic parameters of DAS181. This phase 1 study will be a double-blind, randomized,
      placebo-controlled, single-dose escalation study conducted at Comprehensive Phase One Miramar
      campus. Thirty-six to 60 healthy male and female volunteers, 18-65 years (inclusive), will be
      enrolled in 4 separate steps. Each enrollment will recruit 9 subjects for one of the 4 dose
      groups. Within each dose group, the participants will be randomly assigned to placebo or
      DAS181, at 1:2 ratios. The subjects will receive a single-dose treatment by placebo (10.5 mg
      lactose), or by DAS181 at one of 4 doses: 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg. The subjects
      will be screened and enrolled within 28 days prior to dosing of the study drug. The study
      will be initiated with 0.5 mg dose. Escalation to the next dose will be contingent upon
      meeting the dose escalation criteria after the study day 7 post dosing follow-up visit (Visit
      4). The day of dosing is always defined as Day 0 (or study day 0), regardless of the step or
      cohort. All future visits and time periods are referenced to the day of dosing.
      Administration of DAS181 or placebo will be given under the supervision of the study staff.
      Subjects will enter the inpatient clinic on day -1, the evening prior to dosing. Subjects
      will remain in the inpatient clinic for 24 hours post exposure to be observed for signs of
      adverse events (AEs). After the 24-hour inpatient observation period, participants will be
      discharged if they are deemed healthy at that point. All subjects must come back for
      follow-up visits on the following study days: 2, 7, 14 (±1 day), and 30 (±2 days).
    

Intervention name(s): DAS181; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.; Capsules containing 10.5 mg of lactose will be supplied as placebo.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza, Flu, DAS181, Fludase