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Uncomplicated Flu

Influenza virus causes an acute viral disease of the respiratory tract. Typical influenza (flu) illness is characterized by abrupt onset of fever, headache, muscle pain, sore throat, and nonproductive cough.

The primary objective of this study is to evaluate the efficacy of Drug X administered intramuscularly (i.e., as a needle shot in the arm) compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated influenza.

The basic inclusion criteria are as follows:

• Male and female subjects age ≥18 years;
• A positive Influenza A or B Rapid Antigen Test;
• Presence of fever at time of screening (or 24 hrs prior) of at least 100.4 ºF taken orally;
• Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe);
• Presence of at least one constitutional symptom (muscle aches, headache, feverishness, or fatigue) of any severity (mild, moderate, or severe)
• Onset of illness no more than 48 hours before presentation

The basic exclusion criteria are as follows:

• Presence of clinically significant signs of acute respiratory distress;
• Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening;
• Immunization against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days;
• History of severe chronic obstructive pulmonary disease (COPD), severe persistent asthma, congestive heart failure requiring daily pharmacotherapy within the past 12 months, chronic renal impairment requiring hemodialysis, or known or suspected moderate or severe renal impairment;
• Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics;
• Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy; or
• History of alcohol abuse or drug addiction within the past 1 year

One dose of medication will be given, followed by 2 weeks of safety follow-ups.

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