A Clinical Trial of KT07 Capsule in the U.S.A
A Clinical Trial of KT07 Capsule in the U.S.A
The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation
 of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains,
 fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.
Inclusion Criteria

 1. Subjects with acute uncomplicated influenza with oral temperature ≥ 37.8 ℃ (100.04
 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough); and
 at least one constitutional symptom (aches or pains, fatigue, headache, chills or
 sweats). If antipyretics were taken, may wait at least 4 hours after dosing to
 determine if a qualifying temperature is observed.

 2. Subjects with RIDT confirmed influenza infection.

 3. Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug
 administration visit). The onset of symptoms is defined as either:

 -  Time of the first increase in body temperature to ≥ 37.8 ℃ (100.04 °F); or

 -  Time when the subject experiences at least one general or respiratory symptom.

 4. Age 18 to 65 years old.

 5. Subjects who are able to understand and 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 vasectomized partner with confirmed azoospermia) throughout
 the entire study period, and for 30 days for females and 90 days for males after study
 drug discontinuation.

 Exclusion Criteria

 1. Subjects with severe influenza virus infection requiring inpatient treatment.

 2. Subjects with concurrent infections requiring systemic antimicrobial and/or antiviral
 therapy at the time of screening.

 3. Subjects who have any of the following documented conditions: uncontrolled
 hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm
 Hg), diabetes, asthma (any current or recent, not childhood if resolved), COPD (any),
 cardiac, hepatic, renal (including eGFR<60) and hematopoietic disorders, bleeding
 tendency or hemorrhagic disease, neurological system disease, compromised immune
 system (including patients receiving immunosuppressant therapy, or those with cancer
 within the past 5 years or human immunodeficiency virus [HIV] infection), endocrine
 disorders (including thyroid disorders).

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

 5. Clinically obese subjects with BMI≥40.

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

 7. Received influenza vaccine within 21 days.

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

 9. Pregnant or breast-feeding female subjects

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

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

 12. Previous history of difficulty swallowing capsules.

 13. 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.