This is a randomized, double-blind, placebo-controlled, multicenter, phase II study to be conducted in adults hospitalized with RSV infection in China. The main objectives of this study are to investigate the safety, pharmacokinetics and efficacy of AK0529 in adult RSV patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral, fasting
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal
Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal or fasting
Incidence and severity of AE and SAE of subjects during the study period
An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect, or another important medical event.
Time frame: Baseline up to 28 days
Change from baseline in clinical improvement score of subjects at each visit after treatment by clinical improvement scale
Clinical improvement scale is mainly used to evaluate the overall severity level of the subject's disease with the highest score of 8 indicating death. A score of 6-7 represents severe hospitalization: a score of 6 requires mechanical ventilation, and a score of 7 requires not only mechanical ventilation but also angiogenic treatment, kidney dialysis, or artificial membrane lung. A score of 3-5 represents mild hospitalization: a score of 3 does not require oxygen therapy, a score of 4 requires a mask or nasal catheter, and a score of 5 requires noninvasive positive pressure ventilation or high-flow oxygen therapy. A score of 1-2 represents outpatient treatment: 1 is independent and 2 is in need of care (daily activities have an impact). A score of 0 means no treatment is required and there is no clinical or virological evidence of infection.
Time frame: Baseline up to 28 days
Change from baseline in RiiQ symptoms of subjects at each visit after treatment measured by RiiQ questionnaire
RiiQ questionnaire is mainly used to assess RSV symptoms in patients, including upper respiratory tract infection symptoms (sore throat and nasal congestion), symptoms of lower respiratory tract infection (cough, wheezing, sputum, shortness of breath), and system symptoms (fever, headache, neck pain, fatigue, lack of appetite, interrupted sleep, body aches). The questionnaire is divided into four grading categories of severity including none (0), mild (1), moderate (2) and severe (3).
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The Second Perople's Hospital of Hefei
Hefei, Anhui, China
Huangshan City People's Hospital
Huangshan City, Anhui, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Gansu People's Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
...and 32 more locations
Time frame: Baseline up to 28 days
Changes from baseline in the total score of RSV Symptom of subjects at each visit after treatment using RSV Symptom Score Composite Scale
RSV Symptom Score Composite Scale is used to assess patients with RSV symptoms, including runny nose, stuffy nose, sneezing, sore throat, earache, cough, shortness of breath, headache, fatigue, myalgia and/or joint pain. The score is divided into 4 grades according to the severity of symptoms. 0 indicates no symptoms, 1 indicates occasional symptoms, 2 indicates that symptoms sometimes worsen significantly but do not affect daily activities, and 3 indicates that symptoms are always serious and cannot engage in daily activities. The total score is 30 points.
Time frame: Baseline up to 28 days
Changes from baseline in the RSV VL (viral load) of subjects at each visit after treatment
The RSV VL of subjects' nasopharyngeal samples is measured as Log10 copies/mL by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Time frame: Baseline up to 28 days
Area under the curve (AUCE, last) of RSV Viral Load from baseline to the last measurement
The RSV VL is measured as Log10 copies/mL by qRT-PCR assay in the nasopharyngeal specimens.
Time frame: Baseline up to 28 days
Number of subjects with RSV VL values below the lower limit of quantitation (LLOQ) at each visit after treatment
The RSV VL is measured as Log10 copies/mL by qRT-PCR assay in the nasopharyngeal specimens.
Time frame: Baseline up to 28 days
Number of participants who dropped out of the study due to AE
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to 28 days
Number of participants with laboratory examination abnormalities
Following parameters were analyzed for laboratory examination: hemoglobin (Hb), hematocrit, platelet count, red blood cell (RBC) count, white blood cell (WBC) count, mean corpuscular volume (MCV) and absolute white blood cell line (neutrophils, eosinophils, lymphocytes, monocytes, basophils); Hepatobiliary biochemistry: total and direct bilirubin, total protein, albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP); Renal Function Tests: creatinine kinase, uric acid ; Electrolytes: Sodium, Potassium; Glucose; Coagulation function (subjects with only a history of liver disease should be tested): international normalized ratio (INR), activated partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen; Urine analysis: urine protein, ketone bodies, urine red blood cells, urine white blood cells, and urine glucose; Blood or urine pregnancy test for all female subjects.
Time frame: Baseline up to 28 days
Number of participants with vital sign abnormalities
Number of participants with vital sign (systolic and diastolic blood pressure, pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported.
Time frame: Baseline up to 28 days
Number of participants with physical examination abnormalities
A comprehensive physical examination includes at least cardiovascular, respiratory, gastrointestinal, and nervous system assessments; a simple physical examination includes at least skin, lung, cardiovascular system and abdominal (liver and spleen) assessments.
Time frame: Baseline up to 28 days
Number of participants with ECG abnormalities
Electrocardiograms were measured during the screening period, at 4 (±1) hours after the first dose on day 2, at 4 (±1) hours and 12 (±1) hours (before the second dose) after the first dose on day 4, and once on day 6 and day 14 during the follow-up period; 9-or 12-lead ECG results are recorded using an ECG instrument which automatically calculates heart rate and measures PR, QRS, QT and QTc intervals.
Time frame: Baseline up to 28 days
Peak Plasma Concentration (Cmax)
Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.
Time frame: Day 1, Day 5
Time to Maximum Plasma Concentration (Tmax)
Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.
Time frame: Day 1，Day 5
Terminal Elimination Half-life (t½)
Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.
Time frame: Day 1，Day 5
Apparent Clearance (CL/F)
Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.
Time frame: Day 1，Day 5
Apparent Volume of Distribution (V[z]/F)
Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.
Time frame: Day 1，Day 5
Area Under the Plasma Concentration-Time Curve From Time 0 to 12 (AUC[0-12])
Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.
Time frame: Day 1，Day 5
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞])
Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.
Time frame: Day 1，Day 5