Clinical trial NCT02867358: A Clinical Trial of KT07 Capsule in the U.S.A
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza, Human
Keywords: acute uncomplicated influenza
Lead sponsor: Yiling Pharmaceutical Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-15
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To investigate the improvement in reducing the duration of illness compared to placebo.
timeFrame: Up to 19 days
Secondary outcomes:
measure: The reduction in duration of alleviation of individual symptom
timeFrame: Up to 19 days
measure: Quality of life assessment
timeFrame: Up to 19 days
Other outcomes:
measure: Influenza viral shedding from baseline to Day 3 and Day 6 post treatment initiation during KT07 treatment
timeFrame: Day 1 & 3 & 6
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Birmingham
country: United States
facility: Parkway Medical Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research, Inc.
state: Alabama
city: Pelham
country: United States
facility: David Wever
state: Alabama
city: Tolleson
country: United States
facility: Alliane Urgent Care
state: Arizona
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Cerritos
country: United States
facility: Core Health Care Group
state: California
city: Escondido
country: United States
facility: Aviva Research
state: California
city: Fountain Valley
country: United States
facility: Lalla-Reddy Medical Corp.
state: California
city: Fresno
country: United States
facility: Research Center of Fresno, Inc.
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services, Inc
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center, Inc.
state: California
city: Los Angeles
country: United States
facility: IMD Medical Group
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: San Diego
country: United States
facility: MD Strategies Research Centers
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Denver
country: United States
facility: Cherry Creek Family Practice, PLLC
state: Colorado
city: Denver
country: United States
facility: Urgent Care-Denver
state: Colorado
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Center
state: Connecticut
city: Doral
country: United States
facility: Doral Medical Research
state: Florida
city: Miami Lakes
country: United States
facility: Sweet Hope Research Specialty, Inc
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research Corp.
state: Florida
city: Miami
country: United States
facility: Panamerican Health Center, Inc.
state: Florida
city: Miami
country: United States
facility: AppleMed Reseach, Inc.
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: Tamarac
country: United States
facility: Sunrise Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Sunrise Medical Research
state: Florida
city: Williston
country: United States
facility: Southeast Clinical Research
state: Florida
city: Rincon
country: United States
facility: Invocare (Savannah GA location)
state: Georgia
city: Riverdale
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Blackfoot
country: United States
facility: The Blackfoot Medical Center - Blackfoot
state: Idaho
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C.
state: Indiana
city: Eunice
country: United States
facility: Horizon Research Group of Opelousas, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Centex Studies, Inc
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Rochester
country: United States
facility: Romedica LLC
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Las Vegas
country: United States
facility: Red Rock Clinical Research, LLC
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Manhattan
country: United States
facility: New York Clinical Trials
state: New York
city: Shelby
country: United States
facility: Carolina Research Center, Inc
state: North Carolina
city: Winston-Salem
country: United States
facility: Ardmore Family Practice
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Medical Research International
state: Oklahoma
city: Lansdale
country: United States
facility: Detweiler Family Medicine
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Chattanooga
country: United States
facility: American Family Care Urgent Care
state: Tennessee
city: Franklin
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: Jackson
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: Smyrna
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: Spring Hill
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: Austin
country: United States
facility: Premier Family Physicians
state: Texas
city: Beaumont
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Family Wellness
state: Texas
city: Cypress
country: United States
facility: Northwest Med Care
state: Texas
city: Dallas
country: United States
facility: City Doc Urgent Care
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: San Antonio
country: United States
facility: Quaity Assurance Research Center
state: Texas
city: San Antonio
country: United States
facility: Bandera Family Health Clinic
state: Texas
city: Bountiful
country: United States
facility: Wade Family Medicine
state: Utah
city: Draper
country: United States
facility: J. Lewis Research, Inc./ Foothill Family Clinic Draper
state: Utah
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc./ FirstMed East
state: Utah
city: South Jordan
country: United States
facility: CopperView Medical Center
state: Utah
city: Richmond
country: United States
facility: Clinical Research Partners
state: Virginia
Study officials:
affiliation: Yiling Pharmaceutical Inc.
name: Xuedong Gao, MD
role: STUDY_DIRECTOR
References: