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

Yiling Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Influenza, Human

Treatments: Other: Placebo; Drug: KT07 Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02867358

KT07-US-01

Details and patient eligibility

About

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.

Enrollment: 391 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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391 participants in 3 patient groups, including a placebo group

High dose of KT07 capsule

Active Comparator group

Description:

It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).

Treatment:

Drug: KT07 Capsule

Low dose of KT07 capsule

Active Comparator group

Description:

It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).

Treatment:

Drug: KT07 Capsule

Other: Placebo

Placebo

Placebo Comparator group

Description:

It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.

Treatment:

Other: Placebo