Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed
to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients
aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment
dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by
400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1
day, followed by 800 mg favipiravir BID for 4 days).

Inclusion Criteria:

1. Patients who test positive for influenza A or B by a commercially available Rapid
Antigen Test (RAT) of the nasopharynx. A patient 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.

2. Patients ≥ 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or
more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or
more at the first visit, or in the 6 hours prior if antipyretics were taken.

3. Patients with 2 or more of the following symptoms (moderate to severe in intensity)
at the time of enrollment:

- Cough

- Sore throat

- Headache

- Nasal congestion

- Feeling feverish

- Body aches and pains

- Fatigue (tiredness)

Exclusion Criteria:

1. Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed
under the inclusion criteria) for 36 hours or more prior to study screening.

2. Patients who have underlying chronic respiratory disease (e.g., chronic obstructive
pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis,
bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old
tuberculosis).

3. Patients who at the beginning of the study are suspected of having bacterial
respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or
infiltrate in lung in a chest x-ray, etc.).

4. Patients who have serious chronic diseases. For example, patients with HIV, cancer
(i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage),
and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic
disease states requiring medication dose adjustments within the last 30 days.