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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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
391 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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