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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867358
• Other study ID #: KT07-US-01
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Yiling Pharmaceutical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Drug:
• KT07 Capsule

Other:
• Placebo

Locations

Country	Name	City	State
United States	Orange County Research Institute	Anaheim	California
United States	Premier Family Physicians	Austin	Texas
United States	Pioneer Research Solutions	Beaumont	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Cahaba Research, Inc.	Birmingham	Alabama
United States	Central Alabama Research	Birmingham	Alabama
United States	Parkway Medical Center, LLC	Birmingham	Alabama
United States	The Blackfoot Medical Center - Blackfoot	Blackfoot	Idaho
United States	Wade Family Medicine	Bountiful	Utah
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Hope Clinical Research, Inc.	Canoga Park	California
United States	Family Medicine Associates of Texas	Carrollton	Texas
United States	Core Health Care Group	Cerritos	California
United States	American Family Care Urgent Care	Chattanooga	Tennessee
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Corpus Christi Family Wellness	Corpus Christi	Texas
United States	Northwest Med Care	Cypress	Texas
United States	City Doc Urgent Care	Dallas	Texas
United States	META Medical Research Institute, LLC	Dayton	Ohio
United States	Cherry Creek Family Practice, PLLC	Denver	Colorado
United States	Urgent Care-Denver	Denver	Colorado
United States	Doral Medical Research	Doral	Florida
United States	J. Lewis Research, Inc./ Foothill Family Clinic Draper	Draper	Utah
United States	Centennial Medical Group	Elkridge	Maryland
United States	Aviva Research	Escondido	California
United States	Horizon Research Group of Opelousas, LLC	Eunice	Louisiana
United States	Lalla-Reddy Medical Corp.	Fountain Valley	California
United States	Clinical Research Solutions, LLC	Franklin	Tennessee
United States	Research Center of Fresno, Inc.	Fresno	California
United States	AccuMed Research Associates	Garden City	New York
United States	Centex Studies, Inc.	Houston	Texas
United States	Clinical Research Solutions, LLC	Jackson	Tennessee
United States	Centex Studies, Inc	Lake Charles	Louisiana
United States	Detweiler Family Medicine	Lansdale	Pennsylvania
United States	Red Rock Clinical Research, LLC	Las Vegas	Nevada
United States	Ark Clinical Research	Long Beach	California
United States	Long Beach Clinical Trials Services, Inc	Long Beach	California
United States	Downtown L.A. Research Center, Inc.	Los Angeles	California
United States	IMD Medical Group	Los Angeles	California
United States	New York Clinical Trials	Manhattan	New York
United States	Centex Studies, Inc.	McAllen	Texas
United States	MedPharmics, LLC	Metairie	Louisiana
United States	AppleMed Reseach, Inc.	Miami	Florida
United States	Finlay Medical Research Corp.	Miami	Florida
United States	Florida Research Center, Inc.	Miami	Florida
United States	Panamerican Health Center, Inc.	Miami	Florida
United States	Research Institute of South Florida, Inc.	Miami	Florida
United States	Sweet Hope Research Specialty, Inc	Miami Lakes	Florida
United States	Clinical Research Consulting	Milford	Connecticut
United States	Facey Medical Foundation	Mission Hills	California
United States	Clinical Research Solutions, LLC	Nashville	Tennessee
United States	Comprehensive Psychiatric Center	Norwich	Connecticut
United States	Medical Research International	Oklahoma City	Oklahoma
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	MD Medical Research	Oxon Hill	Maryland
United States	David Wever	Pelham	Alabama
United States	Village Health Partners	Plano	Texas
United States	Clinical Research Partners	Richmond	Virginia
United States	Invocare (Savannah GA location)	Rincon	Georgia
United States	Infinite Clinical Trials	Riverdale	Georgia
United States	Romedica LLC	Rochester	Michigan
United States	Chrysalis Clinical Research	Saint George	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	J. Lewis Research, Inc./ FirstMed East	Salt Lake City	Utah
United States	Bandera Family Health Clinic	San Antonio	Texas
United States	Quaity Assurance Research Center	San Antonio	Texas
United States	MD Strategies Research Centers	San Diego	California
United States	Frontier Clinical Research, LLC	Scottdale	Pennsylvania
United States	Carolina Research Center, Inc	Shelby	North Carolina
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Clinical Research Solutions, LLC	Smyrna	Tennessee
United States	CopperView Medical Center	South Jordan	Utah
United States	Clinical Research Solutions, LLC	Spring Hill	Tennessee
United States	Sunrise Medical Research	Tamarac	Florida
United States	Alliane Urgent Care	Tolleson	Arizona
United States	Empire Clinical Research	Upland	California
United States	Buynak Clinical Research, P.C.	Valparaiso	Indiana
United States	Sunrise Medical Research	West Palm Beach	Florida
United States	Southeast Clinical Research	Williston	Florida
United States	Ardmore Family Practice	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Yiling Pharmaceutical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Quality of life assessment	Based on the self-assessment questionnaire	Up to 19 days