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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Other: Placebo; Drug: KT07 Capsule

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research, Inc.
    • Birmingham, Alabama, United States, 35215
      • Parkway Medical Center, LLC
    • Pelham, Alabama, United States, 35124
      • David Wever
  • Arizona
    • Tolleson, Arizona, United States, 85353
      • Alliane Urgent Care
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Institute
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc.
    • Cerritos, California, United States, 90703
      • Core Health Care Group
    • Escondido, California, United States, 90205
      • AVIVA Research
    • Fountain Valley, California, United States, 92708
      • Lalla-Reddy Medical Corp.
    • Fresno, California, United States, 93702
      • Research Center of Fresno, Inc.
    • Long Beach, California, United States, 90806
      • Ark Clinical Research
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials Services, Inc
    • Los Angeles, California, United States, 90017
      • Downtown L.A. Research Center, Inc.
    • Los Angeles, California, United States, 90020
      • IMD Medical Group
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • San Diego, California, United States, 92119
      • MD Strategies Research Centers
    • Upland, California, United States, 91786
      • Empire Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80246
      • Cherry Creek Family Practice, PLLC
    • Denver, Colorado, United States, 80246
      • Urgent Care-Denver
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Center
  • Florida
    • Doral, Florida, United States, 33166
      • Doral Medical Research
    • Miami, Florida, United States, 33174
      • Florida Research Center, Inc.
    • Miami, Florida, United States, 33126
      • Finlay Medical Research Corp.
    • Miami, Florida, United States, 33126
      • Panamerican Health Center, Inc.
    • Miami, Florida, United States, 33155
      • AppleMed Reseach, Inc.
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida, Inc.
    • Miami Lakes, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc
    • Tamarac, Florida, United States, 33351
      • Sunrise Medical Research
    • West Palm Beach, Florida, United States, 33406
      • Sunrise Medical Research
    • Williston, Florida, United States, 32696
      • Southeast Clinical Research
  • Georgia
    • Rincon, Georgia, United States, 31326
      • Invocare (Savannah GA location)
    • Riverdale, Georgia, United States, 30274
      • Infinite Clinical Trials
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • The Blackfoot Medical Center - Blackfoot
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Buynak Clinical Research, P.C.
  • Louisiana
    • Eunice, Louisiana, United States, 70535
      • Horizon Research Group of Opelousas, LLC
    • Lake Charles, Louisiana, United States, 70601
      • Centex Studies, Inc
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
  • Michigan
    • Rochester, Michigan, United States, 48307
      • Romedica LLC
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group, PLLC
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Red Rock Clinical Research, LLC
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • New York
    • Garden City, New York, United States, 11530
      • Accumed Research Associates
    • Manhattan, New York, United States, 10018
      • New York Clinical Trials
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Carolina Research Center, Inc
    • Winston-Salem, North Carolina, United States, 27103
      • Ardmore Family Practice
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Dayton, Ohio, United States, 45432
      • META Medical Research Institute, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Medical Research International
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research, LLC
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • American Family Care Urgent Care
    • Franklin, Tennessee, United States, 37067
      • Clinical Research Solutions, LLC
    • Jackson, Tennessee, United States, 38305
      • Clinical Research Solutions, LLC
    • Nashville, Tennessee, United States, 37211
      • Clinical Research Solutions, LLC
    • Smyrna, Tennessee, United States, 37167
      • Clinical Research Solutions, LLC
    • Spring Hill, Tennessee, United States, 37174
      • Clinical Research Solutions, LLC
  • Texas
    • Austin, Texas, United States, 78735
      • Premier Family Physicians
    • Beaumont, Texas, United States, 77702
      • Pioneer Research Solutions
    • Carrollton, Texas, United States, 75010
      • Family Medicine Associates of Texas
    • Corpus Christi, Texas, United States, 78414
      • Corpus Christi Family Wellness
    • Cypress, Texas, United States, 77429
      • Northwest Med Care
    • Dallas, Texas, United States, 75230
      • City Doc Urgent Care
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • McAllen, Texas, United States, 78504
      • Centex Studies, Inc.
    • Plano, Texas, United States, 75024
      • Village Health Partners
    • San Antonio, Texas, United States, 78207
      • Quaity Assurance Research Center
    • San Antonio, Texas, United States, 78249
      • Bandera Family Health Clinic
  • Utah
    • Bountiful, Utah, United States, 84010
      • Wade Family Medicine
    • Draper, Utah, United States, 84020
      • J. Lewis Research, Inc./ Foothill Family Clinic Draper
    • Saint George, Utah, United States, 84790
      • Chrysalis Clinical Research
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc. / Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc./ FirstMed East
    • South Jordan, Utah, United States, 84095
      • CopperView Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Clinical Research Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influenza viral shedding from baseline to Day 3 and Day 6 post treatment initiation during KT07 treatment	Reduction in viral shedding; Influenza viral AUC	Day 1 & 3 & 6

Collaborators and Investigators

• Sponsor: Yiling Pharmaceutical Inc.
• Investigators: Study Director: Xuedong Gao, MD, Yiling Pharmaceutical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: acute uncomplicated influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: KT07-US-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No