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

Inclusion criteria

• 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.
• Subjects with RIDT confirmed influenza infection.
• 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.
• Age 18 to 65 years old.
• Subjects who are able to understand and willing to sign the informed consent form (ICF).
• 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

• Subjects with severe influenza virus infection requiring inpatient treatment.
• Subjects with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the time of screening.
• 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).
• Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
• Clinically obese subjects with BMI≥40.
• Subjects with recent history (within 1 year) of alcoholism or substance abuse.
• Received influenza vaccine within 21 days.
• Participation in other clinical trial within 1 month, or during the study.
• Pregnant or breast-feeding female subjects
• Allergy or known allergy to components of study medication.
• Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to enrollment.
• Previous history of difficulty swallowing capsules.
• 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.