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



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:2/6/2019
Start Date:September 2016
End Date:December 2019
Contact:Nan Zhang, PhD
Email:zhangnan@yilingus.net
Phone:614-441-7888

Use our guide to learn which trials are right for you!

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.


Inclusion Criteria

1. Subjects with mild or moderate acute uncomplicated influenza with oral temperature of
37.3-39.3℃ (99.1-102.8°F); plus at least one respiratory symptom (nasal congestion,
sore throat or cough); and at least one constitutional symptoms (aches and pains,
fatigue, headache and chills or sweats).

2. Subjects with RIDT (Rapid Influenza Diagnostic Test) confirmed influenza infection.

3. Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug
administration visit) and receiving no antiviral/antiinfluenza medication.

4. Age 18 to 65 years old.

5. Subjects who are able to understand and are 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 vasectomised partner with confirmed azoospermia) throughout
the entire study period and for 30 days for female and 90 days for male subjects after
study drug discontinuation.

Exclusion Criteria

1. Subjects who suffer from severe influenza with oral temperature of more than 39.3℃
(102.8F) with or without other symptoms.

2. Subjects who have any of the following documented conditions:

hypertension, diabetes, lower respiratory tract infection other than influenza, asthma
requiring daily therapy, including acute flare ofchronic asthma, bronchial asthma,
chronic obstructive pulmonary disease (COPD), acute infectious disease, any other
chronic respiratory disease, bacterial infection of respiratory system, such as:
suppurative tonsillitis, acute tracheobronchitis, sinusitis, otitis; subjects with
history of moderate to severe cardiac, hepatic, renal and hematopoietic disorders,
bleeding tendency or hemorrhagic disease, mental and neurological system disease;
subjects with hyperthyroidism and increased intraocular pressure; and subjects with
current cancer.

3. Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For
example, nasal polyps or significant nasal septal deviation.

4. Subjects who have to take other medications for the treatment of influenza or related
symptoms, including but not limited to antipyretic and analgesic medicines (within 8
hours* prior to randomization), antibiotics, and antiviral drugs.

5. Subjects with acute dyspnea, wheezing, or moist rales on screening examination.

6. Clinically very excessively obese subjects with BMI ≥40.

7. Subjects with recent history (within 1 year) of alcoholism or substance abuse.

8. Received influenza vaccine within 21 days.

9. Participation in other clinical trial within 1 month, or during the study.

10. Pregnant or breast-feeding female subjects.

11. Allergy or known allergy to components of study medication.

12. Allergy to aspirin or non-steroid anti-inflammatory drugs (NSAIDs), such as ibuprofen.

13. Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to
enrollment.

14. Subjects received antipyretic and/or analgesic medications for conditions other than
influenza such as back pain within 8 hours* prior to randomization.

15. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other
than hormone replacement therapy, antiviral and antibacterial drugs during last 4
weeks before the first dose.

16. Previous history of difficulty swallowing capsules.

17. 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. * The
time between administration of antipyretics/analgesics and randomization is 8 hours
for some OTC, such as low dose Aspirin (i.e. 650 mg), Acetaminophen (Tylenol), and
Ibuprofen (Motrin). For high dose Aspirin (i.e. 4-6 g), Celecoxib, Naproxen, and
Diclofenac etc., it is at least 72 hours. Subjects using long half-life drugs, such as
Piroxicam and Oxaprozin, are not eligible to enroll into this study. For other
antipyretics/analgesics, investigator should consider its half-life to make decision
(at least 2-3 half-life recommended).
We found this trial at
63
sites
Eunice, Louisiana 70535
Phone: 337-457-8841
?
mi
from
Eunice, LA
Click here to add this to my saved trials
3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
Phone: 504-304-7197
?
mi
from
Metairie, LA
Click here to add this to my saved trials
2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
?
mi
from
Milford, CT
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Austin, Texas 78735
?
mi
from
Austin, TX
Click here to add this to my saved trials
10700 Stancliff Road
Beaumont, Texas 77702
Phone: 409-833-1748
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Birmingham, Alabama 35215
Phone: 205-876-2601
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35242
Phone: 205-408-4134
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
Canoga Park, California 91303
?
mi
from
Canoga Park, CA
Click here to add this to my saved trials
Carrollton, Texas 75010
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
Cerritos, California 90703
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Phone: 423-531-0911
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Corpus Christi, Texas 78414
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
21212 Northwest Freeway
Cypress, Texas 77429
Phone: 281-890-2121
?
mi
from
Cypress, TX
Click here to add this to my saved trials
5301 West Lovers Lane
Dallas, Texas 75209
Phone: 214-871-7000
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80246
Phone: 303-692-8000
?
mi
from
Denver, CO
Click here to add this to my saved trials
Doral, Florida 33166
Phone: 305-400-9207
?
mi
from
Doral, FL
Click here to add this to my saved trials
?
mi
from
Draper, UT
Click here to add this to my saved trials
Easley, South Carolina 29640
Phone: 864-307-8672
?
mi
from
Easley, SC
Click here to add this to my saved trials
Elkridge, Maryland
?
mi
from
Elkridge, MD
Click here to add this to my saved trials
Escondido, California 92025
Phone: 760-999-2011
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Franklin, Tennessee 37064
?
mi
from
Franklin, TN
Click here to add this to my saved trials
Fresno, California 93726
Phone: 559-225-6765
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Garden City, New York 11530
?
mi
from
Garden City, NY
Click here to add this to my saved trials
Houston, Texas 77062
Phone: 281-282-0808
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
Phone: 337-433-3441
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
1970 North Broad Street
Lansdale, Pennsylvania 19446
?
mi
from
Lansdale, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89146
Phone: 702-629-5311
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California 90017
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90020
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
229 West 36th Street
Manhattan, New York 10018
?
mi
from
Manhattan, NY
Click here to add this to my saved trials
McAllen, Texas 78504
Phone: 956-631-5411
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Miami, Florida 33126
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33126
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida
Phone: 305-279-3545
?
mi
from
Miami, FL
Click here to add this to my saved trials
10555 West Flagler Street
Miami, Florida 33174
Phone: 786-536-9009
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33016
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
Nashville, Tennessee 37211
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Norwich, Connecticut 06360
?
mi
from
Norwich, CT
Click here to add this to my saved trials
Plano, Texas 75024
?
mi
from
Plano, TX
Click here to add this to my saved trials
Richmond, Virginia
?
mi
from
Richmond, VA
Click here to add this to my saved trials
736 South 900 East
Saint George, Utah 84790
Phone: 435-656-1704
?
mi
from
Saint George, UT
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84121
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78207
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78249
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
109 Crossroads Road
Scottdale, Pennsylvania 15683
Phone: 724-220-5281
?
mi
from
Scottdale, PA
Click here to add this to my saved trials
Shelby, North Carolina 28150
Phone: 704-487-5228
?
mi
from
Shelby, NC
Click here to add this to my saved trials
Smithfield, Pennsylvania 15478
Phone: 724-569-8100
?
mi
from
Smithfield, PA
Click here to add this to my saved trials
Smyrna, Tennessee 37167
?
mi
from
Smyrna, TN
Click here to add this to my saved trials
South Jordan, Utah 84095
?
mi
from
South Jordan, UT
Click here to add this to my saved trials
5073 Columbia Pike
Spring Hill, Tennessee 37174
?
mi
from
Spring Hill, TN
Click here to add this to my saved trials
Tamarac, Florida 33351
?
mi
from
Tamarac, FL
Click here to add this to my saved trials
Tolleson, Arizona 85353
Phone: 480-339-5599
?
mi
from
Tolleson, AZ
Click here to add this to my saved trials
Upland, California 91786
?
mi
from
Upland, CA
Click here to add this to my saved trials
West Palm Beach, Florida 33406
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
630 North Main Street
Williston, Florida 32696
?
mi
from
Williston, FL
Click here to add this to my saved trials