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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza

Conditions
-----------------
Influenza, Human

Intervention / Treatment
-----------------
* Drug: KT07 Capsule
* Other: Placebo


Participation Criteria
=================
Eligibility 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose of KT07 capsule<br>It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid). | Drug: KT07 Capsule<br> <br> * Other names: Lianhua Qingwen Capsule;|
| Active Comparator: Low dose of KT07 capsule<br>It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid). | Drug: KT07 Capsule<br> <br> * Other names: Lianhua Qingwen Capsule;Other: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control. | Other: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the improvement in reducing the duration of illness compared to placebo. | Duration of illness is defined as: the length of time to alleviation of all symptoms. The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated. | Up to 19 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction in duration of alleviation of individual symptom | From time zero to the time at which the symptom is less than or equal to mild and stable for at least 24 hours | Up to 19 days | 
| Quality of life assessment | Based on the self-assessment questionnaire | Up to 19 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute uncomplicated influenza