A Study of AK0529 in Adults Patients Hospitalized With RSV Infection
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: Placebo
- Registration Number
- NCT06942299
- Lead Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active drug: AK0529 fasting AK0529 The participants will receive AK0529 twice daily for 5 days from D1 to D5. Active drug: AK0529 with meal AK0529 The participants will receive AK0529 twice daily for 5 days from D1 to D5. Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Incidence and severity of AE and SAE of subjects during the study period Baseline up to 28 days 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.
- Secondary Outcome Measures
Name Time Method Number of subjects with RSV VL values below the lower limit of quantitation (LLOQ) at each visit after treatment Baseline up to 28 days The RSV VL is measured as Log10 copies/mL by qRT-PCR assay in the nasopharyngeal specimens.
Number of participants who dropped out of the study due to AE Baseline up to 28 days An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of participants with vital sign abnormalities Baseline up to 28 days Number of participants with vital sign (systolic and diastolic blood pressure, pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported.
Area under the curve (AUCE, last) of RSV Viral Load from baseline to the last measurement Baseline up to 28 days The RSV VL is measured as Log10 copies/mL by qRT-PCR assay in the nasopharyngeal specimens.
Changes from baseline in the RSV VL (viral load) of subjects at each visit after treatment Baseline up to 28 days The RSV VL of subjects' nasopharyngeal samples is measured as Log10 copies/mL by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Change from baseline in clinical improvement score of subjects at each visit after treatment by clinical improvement scale Baseline up to 28 days 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.
Change from baseline in RiiQ symptoms of subjects at each visit after treatment measured by RiiQ questionnaire Baseline up to 28 days 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).
Changes from baseline in the total score of RSV Symptom of subjects at each visit after treatment using RSV Symptom Score Composite Scale Baseline up to 28 days 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.
Number of participants with laboratory examination abnormalities Baseline up to 28 days 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.
Number of participants with physical examination abnormalities Baseline up to 28 days 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.
Number of participants with ECG abnormalities Baseline up to 28 days 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.
Peak Plasma Concentration (Cmax) Day 1, Day 5 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 to Maximum Plasma Concentration (Tmax) Day 1，Day 5 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.
Terminal Elimination Half-life (t½) Day 1，Day 5 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.
Apparent Clearance (CL/F) Day 1，Day 5 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.
Apparent Volume of Distribution (V[z]/F) Day 1，Day 5 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.
Area Under the Plasma Concentration-Time Curve From Time 0 to 12 (AUC[0-12]) Day 1，Day 5 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.
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Day 1，Day 5 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.
Trial Locations
- Locations (42)
Guizhou People's Hospital
🇨🇳Guiyang, Guizhou, China
The Second Perople's Hospital of Hefei
🇨🇳Hefei, Anhui, China
Huangshan City People's Hospital
🇨🇳Huangshan, Anhui, China
Shunde Hospital of Southern Medical University
🇨🇳Shunde, Guangdong, China
Central People's Hospital of Zhanjiang
🇨🇳Zhanjiang, Guangdong, China
The Second Nanning People's Hospital
🇨🇳Nanning, Guangxi, China
Hebei Chest Hospital
🇨🇳Shijiazhuang, Hebei, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shanxi, China
Chengdu Seventh People's Hospital
🇨🇳Chendu, Sichuan, China
The First Hospital of Kunming
🇨🇳Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
Weifang NO.2 People's Hospital
🇨🇳Weifang, Shandong, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, 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
Longgang Central Hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Harbin Medical University Affiliated Fourth Hospital
🇨🇳Ha'erbin, Heilongjiang, China
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
🇨🇳Ha'erbin, Heilongjiang, China
The Sixth People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Wuhan Fourth Hospital
🇨🇳Wuhan, Hubei, China
Xiangyang Center Hospital
🇨🇳Xiangyang, Hubei, China
Yueyang Central Hospital
🇨🇳Yueyang, Hunan, China
Changzhou Second People's Hospital
🇨🇳Changzhou, Jiangsu, China
Jiangsu Provincial Hospital of Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
The First Affilited Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
The First Clinical College / Liaoning Hospital of TCM
🇨🇳Shenyang, Liaoning, China
Inner Mongolia Autonomous Region People's Hospital
🇨🇳Hohhot, Neimenggu, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Yueyang Hospital Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Sencond Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Shaoxing People's Hospital
🇨🇳Shaoxing, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China