A Study of AK0529 in Adults Patients Hospitalized With RSV Infection
NCT ID: NCT06942299
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2023-07-20
2024-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active drug: AK0529 fasting
The participants will receive AK0529 twice daily for 5 days from D1 to D5.
AK0529
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral, fasting
Active drug: AK0529 with meal
The participants will receive AK0529 twice daily for 5 days from D1 to D5.
AK0529
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal
Placebo
Placebo
Placebo
Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal or fasting
Interventions
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AK0529
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral, fasting
AK0529
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal
Placebo
Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal or fasting
Eligibility Criteria
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Inclusion Criteria
2. . Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.
3. . At least one of the following high-risk diseases or states for RSV infection
1. Asthma or chronic lung disease (such as COPD or cystic fibrosis),
2. immunocompromised,
3. Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
4. Chronic kidney disease,
5. Age ≥65 years old.
4. . With at least 1 new onset respiratory infection symptom or exacerbation of existing respiratory symptoms (respiratory symptoms include: sore throat, nasal congestion, runny nose, sneezing, coughing, wheezing, sputum production, shortness of breath), and any individual score is 2 or moderate.
5. . Onset of RSV infection symptoms should be ≤ 7 days.
Exclusion Criteria
2. . Prohibited medicine are being used or planned to be used during the study treatment periods.
3. . Severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.).
4. . Received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year.
5. . Patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy.
6. . Patients with autoimmune diseases who are in the induction treatment.
7. . HIV infection, CD4 count\< 350 cells/mm3 with opportunistic infection and need treatment.
8. . Other patients who are judged by the investigator to be unsuitable for participating in the study, such as acute/chronic heart, lung, liver, kidney, rheumatic immunity, psychiatric, blood and other diseases in the unstable period.
9. . History of drug abuse within 12 months prior to screening.
10. . Allergy to the investigational drug or its component.
11. . Female patients with positive pregnancy test or breastfeeding.
18 Years
85 Years
ALL
No
Sponsors
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Shanghai Ark Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Longgang Central Hospital of Shenzhen
Shenzhen, Guangdong, 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
Guizhou People's Hospital
Guiyang, Guizhou, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, 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
Weifang NO.2 People's Hospital
Weifang, Shandong, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Yueyang Hospital Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Sencond Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China
The First Hospital of Kunming
Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 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
Countries
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Other Identifiers
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AK0529-2005
Identifier Type: -
Identifier Source: org_study_id
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