A Clinical Trial of KT07 Capsule in the U.S.A

Inclusion Criteria

1. Subjects with mild or moderate acute uncomplicated influenza with oral temperature of
37.3-39.3℃ (99.1-102.8°F); plus at least one respiratory symptom (nasal congestion,
sore throat or cough); and at least one constitutional symptoms (aches and pains,
fatigue, headache and chills or sweats).

2. Subjects with RIDT (Rapid Influenza Diagnostic Test) confirmed influenza infection.

3. Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug
administration visit) and receiving no antiviral/antiinfluenza medication.

4. Age 18 to 65 years old.

5. Subjects who are able to understand and are willing to sign the informed consent form
(ICF).

6. All female subjects of child-bearing potential must have a negative urine pregnancy
test result. All female subjects of child-bearing potential and male subjects and
their spouse/partner must agree to use a medically acceptable method of contraception
(e.g., abstinence, an intrauterine device, a double-barrier method such as condom +
spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral
contraceptive or have a vasectomised partner with confirmed azoospermia) throughout
the entire study period and for 30 days for female and 90 days for male subjects after
study drug discontinuation.

Exclusion Criteria

1. Subjects who suffer from severe influenza with oral temperature of more than 39.3℃
(102.8F) with or without other symptoms.

2. Subjects who have any of the following documented conditions:

hypertension, diabetes, lower respiratory tract infection other than influenza, asthma
requiring daily therapy, including acute flare ofchronic asthma, bronchial asthma,
chronic obstructive pulmonary disease (COPD), acute infectious disease, any other
chronic respiratory disease, bacterial infection of respiratory system, such as:
suppurative tonsillitis, acute tracheobronchitis, sinusitis, otitis; subjects with
history of moderate to severe cardiac, hepatic, renal and hematopoietic disorders,
bleeding tendency or hemorrhagic disease, mental and neurological system disease;
subjects with hyperthyroidism and increased intraocular pressure; and subjects with
current cancer.

3. Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For
example, nasal polyps or significant nasal septal deviation.

4. Subjects who have to take other medications for the treatment of influenza or related
symptoms, including but not limited to antipyretic and analgesic medicines (within 8
hours* prior to randomization), antibiotics, and antiviral drugs.

5. Subjects with acute dyspnea, wheezing, or moist rales on screening examination.

6. Clinically very excessively obese subjects with BMI ≥40.

7. Subjects with recent history (within 1 year) of alcoholism or substance abuse.

8. Received influenza vaccine within 21 days.

9. Participation in other clinical trial within 1 month, or during the study.

10. Pregnant or breast-feeding female subjects.

11. Allergy or known allergy to components of study medication.

12. Allergy to aspirin or non-steroid anti-inflammatory drugs (NSAIDs), such as ibuprofen.

13. Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to
enrollment.

14. Subjects received antipyretic and/or analgesic medications for conditions other than
influenza such as back pain within 8 hours* prior to randomization.

15. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other
than hormone replacement therapy, antiviral and antibacterial drugs during last 4
weeks before the first dose.

16. Previous history of difficulty swallowing capsules.

17. Any other associated disease or condition which, in the opinion of the investigator,
might restrict or impede participation in the study or affect the study results. * The
time between administration of antipyretics/analgesics and randomization is 8 hours
for some OTC, such as low dose Aspirin (i.e. 650 mg), Acetaminophen (Tylenol), and
Ibuprofen (Motrin). For high dose Aspirin (i.e. 4-6 g), Celecoxib, Naproxen, and
Diclofenac etc., it is at least 72 hours. Subjects using long half-life drugs, such as
Piroxicam and Oxaprozin, are not eligible to enroll into this study. For other
antipyretics/analgesics, investigator should consider its half-life to make decision
(at least 2-3 half-life recommended).